DYB INTRODUCER, CATHETER
Report
- Report Number
- 1820334-2025-01404
- Event Type
- Injury
- Date Received
- November 12, 2025
- Date of Event
- March 26, 2021
- Report Date
- March 26, 2026
- Manufacturer
- COOK INC
- Product Code
- DYB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3: THE DATE OF ARTICLE PUBLICATION WAS USED FOR THE EVENT DATE. G4: 510(K) = K142819 OR K153430. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED IN THE LITERATURE, A FEMALE PATIENT DEVELOPED SEIZURES ONE MONTH AFTER A PROCEDURE TO TREAT RECURRENCE OF A RUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY, DURING WHICH A COOK FLEXOR SHUTTLE SHEATH AND OTHER PRODUCTS WITH HYDROPHILIC COATING WERE USED. THE PATIENT HAD A HISTORY OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND THE RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM HAD BEEN TREATED WITH ANOTHER MANUFACTURER¿S COILS TEN YEARS PRIOR. THE RECURRENT ANEURYSM WAS DETECTED ON IMAGING PERFORMED FOR COMPLAINTS OF HEADACHE, AND BECAUSE THE ANATOMY WAS UNFAVORABLE FOR REPEAT COILING AND SURGERY WOULD BE DIFFICULT, THE USER RECOMMENDED PLACEMENT OF A FLOW DIVERTER STENT. AN UNSPECIFIED COOK FLEXOR SHUTTLE SHEATH WAS PLACED IN THE RIGHT INTERNAL CAROTID ARTERY. ANOTHER MANUFACTURER¿S INTERMEDIATE CATHETER WAS USED TO CANNULATE THE PETROUS SEGMENT OVER ANOTHER MANUFACTURER¿S MICROCATHETER AND ANOTHER MANUFACTURER¿S 0.014-INCH WIRE. MULTIPLE ATTEMPTS WERE MADE TO DEPLOY ANOTHER MANUFACTURER¿S STENT; HOWEVER, DUE TO UNFAVORABLE POSITIONING OF THE STENT DEVICE AND REPEATED PROLAPSE WITHIN THE ANEURYSM, THE PROCEDURE WAS ABORTED, AND THE DEVICE WAS REMOVED. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS. ONE MONTH AFTER DISCHARGE, THE PATIENT DEVELOPED PARTIAL SEIZURES IN THE LEFT ARM AND LEG. A BRAIN MRI SHOWED MULTIFOCAL MICRO-NODULAR AREAS OF ENHANCEMENT SURROUNDED BY VASOGENIC EDEMA IN THE RIGHT FRONTAL AND PARIETAL REGIONS OF THE BRAIN (ALSO DESCRIBED AS MULTIFOCAL HYPERINTENSITIES IN THE SUBCORTICAL WHITE MATTER OF THE RIGHT FRONTAL AND PARIETAL LOBES; MULTIPLE SMALL ENHANCING LESIONS WERE NOTED). RESULTS OF AN EXTENSIVE WORK-UP TO DETERMINE AN UNDERLYING CAUSE WERE NEGATIVE. THE ¿WORKING DIAGNOSIS¿ WAS DELAYED INFLAMMATORY REACTION SECONDARY TO HYDROPHILIC POLYMER EMBOLIZATION (HPE). ALTHOUGH TREATMENT WITH STEROIDS WAS CONSIDERED, IT WAS NOT PRESCRIBED DUE TO THE RISKS OF IMMUNOSUPPRESSION WITH THE PATIENT¿S HIV STATUS. THE SEIZURES WERE ADEQUATELY CONTROLLED WITH ANTI-EPILEPTIC MEDICATIONS. EIGHTEEN MONTHS LATER, THE PATIENT UNDERWENT ELECTIVE FLOW DIVERSION. OTHER MANUFACTURERS¿ GUIDE CATHETERS, MICROCATHETERS, AND WIRE WERE USED, AND TWO OVERLAPPING FLOW DIVERSION STENTS (OTHER MANUFACTURER) WERE SUCCESSFULLY DELIVERED. THE MICROCATHETERS AND GUIDE CATHETERS WERE DIFFERENT THAN THE DEVICES USED DURING THE ABORTED PROCEDURE. THE PROCEDURE WAS UNEVENTFUL, WITHOUT IMMEDIATE COMPLICATIONS. TWO DAYS LATER, THE PATIENT DEVELOPED FOCAL SEIZURES AND LEFT-SIDED WEAKNESS. A BRAIN MRI SHOWED WORSENED AND SIGNIFICANT FLAIR HYPERINTENSITIES AND NODULAR ENHANCEMENT IN THE RIGHT FRONTAL AND PARIETAL LOBES, SUGGESTIVE OF RECURRENT GRANULOMATOUS REACTION. DUE TO SIGNIFICANT CLINICAL WORSENING, THE PATIENT WAS TREATED WITH STEROIDS. FOUR MILLIGRAMS OF ORAL DEXAMETHASONE WAS GIVEN EVERY SIX HOURS FOR FIVE DAYS, WITH AN EXCELLENT RESPONSE. THE PATIENT WAS TRANSITIONED TO SIXTY MILLIGRAMS OF ORAL PREDNISONE DAILY, WITH A WEEKLY DECREASE OF TEN MILLIGRAMS. A FOLLOW-UP MRI OF THE BRAIN, PERFORMED TWO-AND-ONE-HALF MONTHS LATER, SHOWED NEARLY COMPLETE RESOLUTION OF THE HYPERINTENSITIES AND ABNORMAL ENHANCEMENT. A REPEAT ANGIOGRAM WAS PERFORMED SIX MONTHS AFTER THE SUCCESSFUL FLOW DIVERSION PROCEDURE, WHICH SHOWED COMPLETE RESOLUTION OF THE RECURRENT ANEURYSM, WITH OCCLUSION OF THE RESIDUAL ANEURYSM AND RECONSTRUCTION OF THE SUPRACLINOID CAROTID ARTERY. THE AUTHORS NOTE THAT ALTHOUGH THE DIAGNOSIS OF A FOREIGN BODY REACTION DUE TO HPE WAS NOT CONFIRMED WITH BIOPSY, THE DIAGNOSIS WAS MADE BASED ON THE TIMELINE OF SYMPTOMS AND IMAGING FINDINGS EXCLUSIVELY IN THE RIGHT CEREBRAL HEMISPHERE. THE AUTHORS ALSO NOTE THAT ALL NEURO-ENDOVASCULAR TOOLS USED DURING BOTH THE ABORTED AND SUCCESSFUL PROCEDURES WERE COATED WITH HYDROPHILIC MATERIALS, AND THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT SOURCE OF THE EMBOLIC MATERIAL. THE AUTHORS HYPOTHESIZE THAT THE SOURCE OF THE EMBOLIC MATERIAL MAY HAVE BEEN THE FLOW DIVERTER, SINCE THE ABORTED ATTEMPT WAS TECHNICALLY CHALLENGING AND REQUIRED MULTIPLE ATTEMPTS OF PARTIAL UNSHEATHING/RE-SHEATHING, AND BACK AND FORTH MOVEMENT OF THE DENSELY COATED FLOW DIVERTER IN THE DYSPLASTIC SUPRACLINOID INTERNAL CAROTID ARTERY, WHICH MAY HAVE CAUSED THE HYDROPHILIC COATING OF THE FLOW DIVERTER TO DISLODGE AND ¿SHOWER¿ DISTALLY. HYDROPHILIC TOOLS WERE USED IN THE UNEVENTFUL COILING PROCEDURE TEN YEARS PRIOR. THE AUTHORS STATE THAT THE ONLY COMMON TOOL USED IN BOTH THE FIRST (ABORTED) PROCEDURE AND THE SECOND (SUCCESSFUL FLOW DIVERSION) PROCEDURE WAS THE OTHER MANUFACTURER¿S FLOW DIVERTER, AND NOTE THAT THE GUIDE CATHETER, INTERMEDIATE CATHETER, AND MICROCATHETER WERE INTENTIONALLY CHANGED FOR THE SECOND PROCEDURE. IT IS UNKNOWN WHAT SHEATH WAS USED IN THE SECOND PROCEDURE. THE AUTHORS ALSO STATE THAT HPE HAS BEEN REPORTED AFTER PLACEMENT OF FLOW DIVERTER DEVICES. THE AUTHORS NOTE THAT THE RAPID FLARE-UP AFTER THE SECOND EXPOSURE IS TYPICAL OF A TYPE IV GRANULOMATOUS HYPERSENSITIVITY REACTION, AS RE-EXPOSURE TO THE FOREIGN BODY REACTIVATES SPECIFIC MEMORY T-CELLS, TRIGGERING AN ACCELERATED REACTION. THERE HAS BEEN NO ALLEGATION THAT THE HYDROPHILIC COATING OF THE COOK FLEXOR SHUTTLE SHEATH SEPARATED IN THIS CASE. CITATION FOR ARTICLE: ABDALKADER, M., SATHYA, A., MA, A., CERVANTES-ARSLANIAN, A. M., CHUNG, D. Y., BAREST, G., & NGUYEN, T. N. (2021). HYDROPHILIC POLYMER EMBOLIZATION FOLLOWING FLOW DIVERSION OF CEREBRAL ANEURYSMS. THE NEURORADIOLOGY JOURNAL, 34(4), 363¿369. HTTPS://DOI.ORG/10.1177/19714009211004185. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A SEARCH OF SALES WAS UNABLE TO DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿IF THE DEVICE HAS HYDROPHILIC COATING, ACTIVATE THE COATING BY WETTING THE OUTER SURFACE OF THE DEVICE WITH HEPARINIZED SALINE. NOTE: FOR BEST RESULTS, MAINTAIN WETTED CONDITION OF DEVICE DURING PLACEMENT.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. ALTHOUGH THERE WAS NO DIRECT ALLEGED MALFUNCTION OF THE COOK SHEATH, EMBOLIZATION OF HYDROPHILIC MATERIAL OCCURRED DURING A PROCEDURE IN WHICH THE COOK SHEATH WAS USED. FRICTION BETWEEN HYDROPHILICALLY-COATED DEVICES MAY HAVE CONTRIBUTED TO THE EVENT, AND THE AUTHORS HYPOTHESIZE THAT THE SOURCE OF THE EMBOLIC MATERIAL MAY HAVE BEEN THE FLOW DIVERTER, SINCE THE ABORTED ATTEMPT WAS TECHNICALLY CHALLENGING AND REQUIRED MULTIPLE ATTEMPTS OF PARTIAL UNSHEATHING/RE-SHEATHING. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
AS REPORTED IN THE LITERATURE, A FEMALE PATIENT DEVELOPED SEIZURES ONE MONTH AFTER A PROCEDURE TO TREAT RECURRENCE OF A RUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY, DURING WHICH A COOK FLEXOR SHUTTLE SHEATH AND OTHER PRODUCTS WITH HYDROPHILIC COATING WERE USED. THE PATIENT HAD A HISTORY OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND THE RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM HAD BEEN TREATED WITH ANOTHER MANUFACTURER¿S COILS TEN YEARS PRIOR. THE RECURRENT ANEURYSM WAS DETECTED ON IMAGING PERFORMED FOR COMPLAINTS OF HEADACHE, AND BECAUSE THE ANATOMY WAS UNFAVORABLE FOR REPEAT COILING AND SURGERY WOULD BE DIFFICULT, THE USER RECOMMENDED PLACEMENT OF A FLOW DIVERTER STENT. AN UNSPECIFIED COOK FLEXOR SHUTTLE SHEATH WAS PLACED IN THE RIGHT INTERNAL CAROTID ARTERY. ANOTHER MANUFACTURER¿S INTERMEDIATE CATHETER WAS USED TO CANNULATE THE PETROUS SEGMENT OVER ANOTHER MANUFACTURER¿S MICROCATHETER AND ANOTHER MANUFACTURER¿S 0.014-INCH WIRE. MULTIPLE ATTEMPTS WERE MADE TO DEPLOY ANOTHER MANUFACTURER¿S STENT; HOWEVER, DUE TO UNFAVORABLE POSITIONING OF THE STENT DEVICE AND REPEATED PROLAPSE WITHIN THE ANEURYSM, THE PROCEDURE WAS ABORTED, AND THE DEVICE WAS REMOVED. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS. ONE MONTH AFTER DISCHARGE, THE PATIENT DEVELOPED PARTIAL SEIZURES IN THE LEFT ARM AND LEG. A BRAIN MRI SHOWED MULTIFOCAL MICRO-NODULAR AREAS OF ENHANCEMENT SURROUNDED BY VASOGENIC EDEMA IN THE RIGHT FRONTAL AND PARIETAL REGIONS OF THE BRAIN (ALSO DESCRIBED AS MULTIFOCAL HYPERINTENSITIES IN THE SUBCORTICAL WHITE MATTER OF THE RIGHT FRONTAL AND PARIETAL LOBES; MULTIPLE SMALL ENHANCING LESIONS WERE NOTED). RESULTS OF AN EXTENSIVE WORK-UP TO DETERMINE AN UNDERLYING CAUSE WERE NEGATIVE. THE ¿WORKING DIAGNOSIS¿ WAS DELAYED INFLAMMATORY REACTION SECONDARY TO HYDROPHILIC POLYMER EMBOLIZATION (HPE). ALTHOUGH TREATMENT WITH STEROIDS WAS CONSIDERED, IT WAS NOT PRESCRIBED DUE TO THE RISKS OF IMMUNOSUPPRESSION WITH THE PATIENT¿S HIV STATUS. THE SEIZURES WERE ADEQUATELY CONTROLLED WITH ANTI-EPILEPTIC MEDICATIONS. EIGHTEEN MONTHS LATER, THE PATIENT UNDERWENT ELECTIVE FLOW DIVERSION. OTHER MANUFACTURERS¿ GUIDE CATHETERS, MICROCATHETERS, AND WIRE WERE USED, AND TWO OVERLAPPING FLOW DIVERSION STENTS (OTHER MANUFACTURER) WERE SUCCESSFULLY DELIVERED. THE MICROCATHETERS AND GUIDE CATHETERS WERE DIFFERENT THAN THE DEVICES USED DURING THE ABORTED PROCEDURE. THE PROCEDURE WAS UNEVENTFUL, WITHOUT IMMEDIATE COMPLICATIONS. TWO DAYS LATER, THE PATIENT DEVELOPED FOCAL SEIZURES AND LEFT-SIDED WEAKNESS. A BRAIN MRI SHOWED WORSENED AND SIGNIFICANT FLAIR HYPERINTENSITIES AND NODULAR ENHANCEMENT IN THE RIGHT FRONTAL AND PARIETAL LOBES, SUGGESTIVE OF RECURRENT GRANULOMATOUS REACTION. DUE TO SIGNIFICANT CLINICAL WORSENING, THE PATIENT WAS TREATED WITH STEROIDS. FOUR MILLIGRAMS OF ORAL DEXAMETHASONE WAS GIVEN EVERY SIX HOURS FOR FIVE DAYS, WITH AN EXCELLENT RESPONSE. THE PATIENT WAS TRANSITIONED TO SIXTY MILLIGRAMS OF ORAL PREDNISONE DAILY, WITH A WEEKLY DECREASE OF TEN MILLIGRAMS. A FOLLOW-UP MRI OF THE BRAIN, PERFORMED TWO-AND-ONE-HALF MONTHS LATER, SHOWED NEARLY COMPLETE RESOLUTION OF THE HYPERINTENSITIES AND ABNORMAL ENHANCEMENT. A REPEAT ANGIOGRAM WAS PERFORMED SIX MONTHS AFTER THE SUCCESSFUL FLOW DIVERSION PROCEDURE, WHICH SHOWED COMPLETE RESOLUTION OF THE RECURRENT ANEURYSM, WITH OCCLUSION OF THE RESIDUAL ANEURYSM AND RECONSTRUCTION OF THE SUPRACLINOID CAROTID ARTERY. THE AUTHORS NOTE THAT ALTHOUGH THE DIAGNOSIS OF A FOREIGN BODY REACTION DUE TO HPE WAS NOT CONFIRMED WITH BIOPSY, THE DIAGNOSIS WAS MADE BASED ON THE TIMELINE OF SYMPTOMS AND IMAGING FINDINGS EXCLUSIVELY IN THE RIGHT CEREBRAL HEMISPHERE. THE AUTHORS ALSO NOTE THAT ALL NEURO-ENDOVASCULAR TOOLS USED DURING BOTH THE ABORTED AND SUCCESSFUL PROCEDURES WERE COATED WITH HYDROPHILIC MATERIALS, AND THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT SOURCE OF THE EMBOLIC MATERIAL. THE AUTHORS HYPOTHESIZE THAT THE SOURCE OF THE EMBOLIC MATERIAL MAY HAVE BEEN THE FLOW DIVERTER, SINCE THE ABORTED ATTEMPT WAS TECHNICALLY CHALLENGING AND REQUIRED MULTIPLE ATTEMPTS OF PARTIAL UNSHEATHING/RE-SHEATHING, AND BACK AND FORTH MOVEMENT OF THE DENSELY COATED FLOW DIVERTER IN THE DYSPLASTIC SUPRACLINOID INTERNAL CAROTID ARTERY, WHICH MAY HAVE CAUSED THE HYDROPHILIC COATING OF THE FLOW DIVERTER TO DISLODGE AND ¿SHOWER¿ DISTALLY. HYDROPHILIC TOOLS WERE USED IN THE UNEVENTFUL COILING PROCEDURE TEN YEARS PRIOR. THE AUTHORS STATE THAT THE ONLY COMMON TOOL USED IN BOTH THE FIRST (ABORTED) PROCEDURE AND THE SECOND (SUCCESSFUL FLOW DIVERSION) PROCEDURE WAS THE OTHER MANUFACTURER¿S FLOW DIVERTER, AND NOTE THAT THE GUIDE CATHETER, INTERMEDIATE CATHETER, AND MICROCATHETER WERE INTENTIONALLY CHANGED FOR THE SECOND PROCEDURE. IT IS UNKNOWN WHAT SHEATH WAS USED IN THE SECOND PROCEDURE. THE AUTHORS ALSO STATE THAT HPE HAS BEEN REPORTED AFTER PLACEMENT OF FLOW DIVERTER DEVICES. THE AUTHORS NOTE THAT THE RAPID FLARE-UP AFTER THE SECOND EXPOSURE IS TYPICAL OF A TYPE IV GRANULOMATOUS HYPERSENSITIVITY REACTION, AS RE-EXPOSURE TO THE FOREIGN BODY REACTIVATES SPECIFIC MEMORY T-CELLS, TRIGGERING AN ACCELERATED REACTION. THERE HAS BEEN NO ALLEGATION THAT THE HYDROPHILIC COATING OF THE COOK FLEXOR SHUTTLE SHEATH SEPARATED IN THIS CASE. CITATION FOR ARTICLE: ABDALKADER, M., SATHYA, A., MA, A., CERVANTES-ARSLANIAN, A. M., CHUNG, D. Y., BAREST, G., & NGUYEN, T. N. (2021). HYDROPHILIC POLYMER EMBOLIZATION FOLLOWING FLOW DIVERSION OF CEREBRAL ANEURYSMS. THE NEURORADIOLOGY JOURNAL, 34(4), 363¿369. HTTPS://DOI.ORG/10.1177/19714009211004185.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327395 | DYB INTRODUCER, CATHETER | DYB | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |