ARROW CATH-LAB SHEATH INTRO SET
Report
- Report Number
- 9680794-2021-00654
- Event Type
- Malfunction
- Date Received
- December 21, 2021
- Date of Event
- December 1, 2021
- Report Date
- December 1, 2021
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(6). THE CUSTOMER RETURNED ONE 5 FR SHEATH FOR EVALUATION. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED. THE NON-ARROW CATHETER THAT THE CUSTOMER REPORTED WAS USED IN TANDEM WITH THE ARROW SHEATH WAS NOT RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE SHEATH DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE BODY, SHEATH VALVES OR EXTENSION ARM. THE SHEATH BODY LENGTH MEASURED FROM THE HEMOSTASIS VALVE TO THE TIP MEASURED 9 3/8" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8 7/8"-9 3/4" PER THE SHEATH EXT WITH DILATOR GRAPHIC. THE INNER DIAMETER AT THE SHEATH TIP MEASURED .072" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .070"-.072" PER THE SHEATH EXT WITH DILATOR GRAPHIC. THE SHEATH OUTER DIAMETER MEASURED .1025" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .099"-.103" PER THE SHEATH EXT WITH DILATOR GRAPHIC. AS THE NON-ARROW CATHETER WAS NOT RETURNED BY THE CUSTOMER, A .066" PIN GAGE WAS INSERTED THROUGH THE RETURNED SHEATH VALVE TO MIMIC A 5FR CATHETER (5FR = .066"). LITTLE TO NO RESISTANCE WAS OBSERVED AS THE PIN GAGE WAS ABLE TO PASS COMPLETELY THROUGH THE SHEATH. PERFORMED PER IFU STATEMENT "INTRODUCE TIP OF DESIRED DEVICE THROUGH HEMOSTASIS VALVE AND ADVANCE THROUGH SHEATH INTO VESSEL TO DESIRED POSITION". R & D WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY INDICATED THAT SINCE THE NON-ARROW CATHETER WAS NOT RETURNED FOR ANALYSIS, IT CANNOT BE DETERMINED HOW IT INTERACTS WITH THE RETURNED SHEATH. ADDITIONALLY, THE DESIGN SPECIFICATION LIMITS OF THE NON-ARROW CATHETER CANNOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDE WIRE OR SHEATH/DILATOR. IF WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, DETERMINE CAUSE USING FLUOROSCOPIC GUIDANCE AND REQUEST FURTHER CONSULTATION, IF NECESSARY". THE REPORT OF A SHEATH TIGHT OVER NON-ARROW CATHETER COULD NOT BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE RETURNED SHEATH. ADDITIONALLY, THE SHEATH MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. THE REPORTED ISSUE COULD NOT BE REPRODUCED WITH THE RETURNED ARROW SHEATH AND THE NON-ARROW CATHETER USED IN THE EVENT WAS NOT RETURNED. BASED ON THESE CIRCUMSTANCES AND THE COMMENTS FROM R & D, THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
(B)(4).
IT WAS REPORTED THE USER FELT A STRONG RESISTANCE WHEN INSERTING A 5FR. CATHETER INTO THE SHEATH. THE CATHETER WAS REPLACED WITH A 4FR. AND INSERTED, ALTHOUGH THERE WAS STILL SOME RESISTANCE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
IT WAS REPORTED THE USER FELT A STRONG RESISTANCE WHEN INSERTING A 5FR. CATHETER INTO THE SHEATH. THE CATHETER WAS REPLACED WITH A 4FR. AND INSERTED, ALTHOUGH THERE WAS STILL SOME RESISTANCE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1952439 | ARROW CATH-LAB SHEATH INTRO SET | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL INC. | 14F21B0264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 5 FR. CATHETER (NON-TELEFLEX PRODUCT).| 5 FR. CATHETER (NON-TELEFLEX PRODUCT). |