FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
Report
- Report Number
- 1820334-2019-02990
- Event Type
- Malfunction
- Date Received
- December 4, 2019
- Date of Event
- November 14, 2019
- Report Date
- May 29, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002311206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
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, UNAVAILABLE, OR UNCHANGED. INITIAL REPORT: AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING STENOSIS OF THE CAROTID ARTERY, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH LEAKED AT THE TUOHY-BORST VALVE. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND THE DEVICE WAS ADVANCED TO "RIGHT BEFORE" THE JUGULAR VEIN. BLOOD LEAKAGE FROM THE VALVE OCCURRED UPON INSERTION OF THE DEVICE INTO THE BODY. THE USER TIGHTENED THE VALVE; HOWEVER, THE LEAK CONTINUED. AN "EQUIVALENT PRODUCT" WAS THEN USED IN PLACE OF THE COMPLAINT DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY OR THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THE EVENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, A VISUAL INSPECTION AND A FUNCTIONAL TEST OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE ONE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH (KSAW-6.0-38-90-RB-SHTL) WAS RETURNED. THERE WAS NO EVIDENCE OF BIO-MATTER PRESENT OR ANY DAMAGE TO THE DEVICE. LEAK TESTING WAS PERFORMED AND THERE WAS NO EVIDENCE OF A LEAK. TESTING COULD NOT REPLICATE THE REPORTED FAILURE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE EVIDENCE INDICATES THE PRODUCT WAS MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES ¿INSERT THE DILATOR COMPLETELY INTO THE SHEATH. IF THE SHEATH HAS A TUOHY-BORST VALVE, TIGHTEN THE VALVE AROUND THE DILATOR." THERE WAS NO DAMAGE IDENTIFIED DURING THE DEVICE ANALYSIS AND THE REPORTED FAILURE COULD NOT BE REPLICATED. THERE WERE NO ISSUES IDENTIFIED WITH THE DEVICE. BASED ON THE DEVICE MASTER RECORD AND DEVICE HISTORY RECORD REVIEWS, THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL OR ADDITIONAL COMPLAINTS FROM THIS LOT IN THE FIELD. THIS EVENT LIKELY OCCURRED DUE TO PROCEDURAL TECHNIQUE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
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. 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.
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.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
(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 STENOSIS OF THE CAROTID ARTERY, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH LEAKED AT THE TUOHY-BORST VALVE. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND THE DEVICE WAS ADVANCED TO "RIGHT BEFORE" THE JUGULAR VEIN. BLOOD LEAKAGE FROM THE VALVE OCCURRED UPON INSERTION OF THE DEVICE INTO THE BODY. THE USER TIGHTENED THE VALVE; HOWEVER, THE LEAK CONTINUED. AN "EQUIVALENT PRODUCT" WAS THEN USED IN PLACE OF THE COMPLAINT DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY OR THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THE EVENT. 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 |
|---|---|---|---|---|---|---|---|
| 1205989 | FLEXOR SHUTTLE TIBIAL GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | 9923400 | 00827002311206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |