FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
Report
- Report Number
- 1820334-2020-00135
- Event Type
- Malfunction
- Date Received
- January 16, 2020
- Date of Event
- January 9, 2020
- Report Date
- May 29, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002311206
- PMA / PMN Number
- K142819
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
THE PROCEDURE WAS ANGIOPLASTY AND STENTING OF THE CAROTID ARTERY. 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.
THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: D2B: DEVICE NOT CLEARED FOR SALE IN THE US. PRODUCT CODE OF SIMILAR DEVICE: DYB G5: DEVICE NOT CLEARED FOR SALE IN THE US. 510(K)# OF SIMILAR DEVICE: K142819 THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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, DURING ANGIOPLASTY AND STENTING OF A STENOSED CAROTID ARTERY, THE VALVE OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH LEAKED. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND ADVANCED TO THE INTERNAL CAROTID ARTERY. BLOOD WAS OBSERVED TO BE DRIPPING FROM THE TUOHY-BORST VALVE. THE PHYSICIAN ATTEMPTED TO TURN THE VALVE TO STOP THE LEAK; HOWEVER, THE LEAK CONTINUED. THE PHYSICIAN REMOVED THE DEVICE AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT REQUIRE ANY INTERVENTION FOR BLOOD LOSS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION, AS WELL AS A VISUAL INSPECTION OF THE COMPLAINT DEVICE. THE COMPLAINT DEVICE WAS RETURNED, AND A LEAK TEST WAS PERFORMED BY CLOSING THE TUOHY-BORST VALVE, CLOSING OFF THE LUMEN OF THE SHEATH WITH A HEMOSTAT, AND INTRODUCING WATER THROUGH THE SIDEARM. NO LEAKAGE WAS DETECTED DURING THIS TEST. THE DEVICE WAS ALSO INSPECTED FOR DAMAGE AND NO DAMAGE WAS NOTED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, VALIDATIONS, AND MANUFACTURING DOCUMENTS PROVIDE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE PRODUCT IFU STATES: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE IFU ALSO LISTS BLEEDING AS AN ADVERSE EFFECT THAT MAY BE ASSOCIATED WITH USE OF AN INTRODUCER. A REVIEW OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS EVENT CANNOT BE DETERMINED; HOWEVER, POSSIBLE REASONS FOR THE FAILURE INCLUDE THE PATIENT'S ANATOMY, THE NATURE OF THE PROCEDURE, AND/OR USER HANDLING. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
(B)(6). PMA/510(K) NUMBER = PRE-AMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING A PATIENT WITH CAROTID ARTERY STENOSIS, THE VALVE OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH LEAKED. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND ADVANCED TO THE INTERNAL CAROTID ARTERY. BLOOD WAS OBSERVED TO BE DRIPPING FROM THE TUOHY-BORST VALVE. THE PHYSICIAN ATTEMPTED TO TURN THE VALVE TO STOP THE LEAK; HOWEVER, THE LEAK CONTINUED. THE PHYSICIAN REMOVED THE DEVICE AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT REQUIRE ANY INTERVENTION FOR BLOOD LOSS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61017 | FLEXOR SHUTTLE TIBIAL GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | 10132619 | 00827002311206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |