ARROW CATH-LAB SHEATH INTRO SET:
Report
- Report Number
- 9680794-2022-00416
- Event Type
- Malfunction
- Date Received
- July 13, 2022
- Date of Event
- June 24, 2022
- Report Date
- June 24, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CONCOMITANT MEDICAL PRODUCTS: AUNCHER CORONARY GUIDE CATHETER (7FR, CATALOG# UNKNOWN) (B)(4).
CONTINUATION OF D11: AUNCHER CORONARY GUIDE CATHETER (7FR, CATALOG# UNKNOWN) (B)(4). THE CUSTOMER RETURNED ONE, ARROW SHEATH AND A LIDSTOCK FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED. THE NON-ARROW SHEATH MENTIONED BY THE CUSTOMER WAS NOT RETURNED FOR ANALYSIS. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES OF ANY KIND. THE SHEATH LENGTH FROM THE CAP TO THE DISTAL TIP MEASURED 17 5/8", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 17 1/18"-18 1/8" PER THE SHEATH WITH DILATOR ASSEMBLY PRODUCT DRAWING. THE SHEATH OUTER DIAMETER MEASURED .127", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .124"-.128" PER THE WRAPPED EXTRUSION PRODUCT DRAWING. THE SHEATH INNER DIAMETER AT THE DISTAL TIP MEASURED .097", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .097"-.099" PER THE SHEATH WITH DILATOR ASSEMBLY PRODUCT DRAWING. A LAB INVENTORY, 7FR NON-ARROW CATHETER WAS INSERTED THROUGH THE RETURNED SHEATH. LITTLE TO NO RESISTANCE WAS OBSERVED AS THE NON-ARROW CATHETER WAS ABLE TO PASS COMPLETELY THROUGH THE ASSEMBLY. PERFORMED PER IFU STATEMENT, "INTRODUCE TIP OF DESIRED DEVICE THROUGH HEMOSTASIS VALVE AND ADVANCE THROUGH SHEATH INTO VESSEL TO DESIRED POSITION". FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED WITH THE NON-ARROW CATHETER INVOLVED WITH THIS COMPLAINT AS IT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT WITHDRAW DILATOR UNTIL SHEATH IS WELL WITHIN VESSEL TO MINIMIZE THE RISK OF SHEATH TIP DAMAGE". THE REPORT OF A SHEATH TIGHT OVER NON-ARROW CATHETER WAS NOT ABLE TO BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE RETURNED SHEATH. ADDITIONALLY , ALL DIMENSIONAL AND FUNCTIONAL REQUIREMENTS WERE MET, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT THE ACTUAL NON-ARROW CATHETER ALSO RETURNED FOR ANALYSIS. THEREFORE, THE ROOT CAUSE IS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED THE FIRST GUIDING CATHETER (7F ASAHI HYPERION) GOT STUCK IN THE SHEATH DURING INSERTION. THE CATHETER WAS REPLACED WITH A SECOND ONE (7F LAUNCHER CORONARY GUIDE CATHETER) AND SUCCESSFULLY INSERTED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
IT WAS REPORTED THE FIRST GUIDING CATHETER (7F ASAHI HYPERION) GOT STUCK IN THE SHEATH DURING INSERTION. THE CATHETER WAS REPLACED WITH A SECOND ONE (7F LAUNCHER CORONARY GUIDE CATHETER) AND SUCCESSFULLY INSERTED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402010 | ARROW CATH-LAB SHEATH INTRO SET: | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | 14F21D0278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ASAHI HYPERION (7FR, CATALOG#: HJ70JL400P10000), L| ASAHI HYPERION (7FR, CATALOG#: HJ70JL400P10000), L |