FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
Report
- Report Number
- 1820334-2019-02282
- Event Type
- Malfunction
- Date Received
- September 12, 2019
- Date of Event
- September 6, 2019
- Report Date
- May 29, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002311244
- PMA / PMN Number
- K142819
- 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. DEVICE NOT CLEARED FOR SALE IN THE US. PRODUCT CODE OF SIMILAR DEVICE: DYB. 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.
THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. 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. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS RETURNED TO COOK FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH BIO-MATTER THROUGHOUT, THE DILATOR INSERTED, AND THE SHEATH AND DILATOR SLIGHTLY BENT. THE HUB OF THE SHEATH WAS SEPARATED FROM THE SHEATH WITH NO TUBING REMAINING IN THE HUB. NO FURTHER DAMAGE WAS NOTED TO THE DEVICE. THE SHEATH FLARE PASSED THE FLARE GAUGE TEST. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NONCONFORMING EVENT WHICH COULD POTENTIALLY RELATE TO THIS FAILURE MODE, BUT THE AFFECTED UNIT WAS SCRAPPED PRIOR TO ORDER COMPLETION. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. AN IFU IS PROVIDED WITH THE DEVICE, WHICH WARNS "IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OF FLEXOR SHEATH, ASSESS CAUSE OF RESISTANCE AND CONSIDER DILATION OF ANY RESTRICTION IDENTIFIED OR CONSIDER ALTERNATE TREATMENT STRATEGY. IF FLEXOR SHEATH IS ADVANCED THROUGH RESISTANCE, FORCE TO REMOVE THE SHEATH WILL BE HIGHER, INCREASING THE RISK OF SHEATH MATERIAL OR HUB SEPARATION UPON WITHDRAWAL." THE IFU FURTHER WARNS, "REINSERTION OF THE DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH AND LESSENS THE RISK OF DEVICE SEPARATION. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OR FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL." BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THIS EVENT COULD NOT BE TRACED TO THE DEVICE, BUT TO THE PATIENT¿S ANATOMY. REPORTEDLY, THERE WAS CALCIFICATION AT THE BIFURCATION. 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.
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 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. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, THE HUB OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH SEPARATED FROM THE DEVICE. ANOTHER MANUFACTURER'S BALLOON WAS USED VIA ACCESS IN THE RIGHT FEMORAL ARTERY. AS THE USER ATTEMPTED TO ADVANCE THE COMPLAINT DEVICE CONTRALATERALLY, IT BECAME STUCK AT THE BIFURCATION DUE TO CALCIFICATION. THE USER THEN APPLIED FORCE TO THE DEVICE AND TRACTION TO THE HUB, AND THE SHEATH DETACHED FROM THE HUB. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 803830 | FLEXOR SHUTTLE TIBIAL GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | 9020070 | 00827002311244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GORE'S VIABAHN 7 MM |