MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH-LAB SHEATH INTRO SET:; CATHETER PERCUTANEOUS

Model Number	IPN920047
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "dilator could not be put into the sheath there was a kink in the sheath".The issue was detected prior to insertion.It was reported there was a minimum delay to replace the sheath.
Event or Problem Description
It was reported "dilator could not be put into the sheath there was a kink in the sheath".The issue was detected prior to insertion.It was reported there was a minimum delay to replace the sheath.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened sheath/dilator assembly for analysis.No definite signs of use were observed on the returned components.Visual analysis revealed that the sheath body was kinked.Microscopic examination confirmed the damage.The damage appears consistent with defects caused by shipping and handling.It was also noted that the sheath pouch was returned severely folded and creased in several locations.When placing the sheath back into the pouch , the kink on the sheath was in the same location as one of the creases in the pouch.The crushed section of the returned sheath measured 77mm from the distal tip.The sheath body length from the hub to the distal tip measured 18", which is within the specification limits of 17 1/8"-18 1/8" per the sheath ext with dilator product drawing.The sheath body outer diameter in an area that was not crushed measured 0.1274", which is within the specification limits of 0.124"-0.128" per the sheath wrapped product drawing.The sheath inner diameter at the distal tip measured 0.097" , which is within the specification limits of 0.097"-0.099" per the sheath ext with dilator product drawing.The dilator was inserted through the proximal end of the sheath.Despite the damage to the sheath, the dilator was able to pass with little to no issues.Performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".Packaging r & d was contacted and they indicated that the failure mode appears consistent with damage due to storage/shipping.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "precaution: do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage.Do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished , determine cause using fluoroscopic guidance and request further consultation, if necessary." the report of a damaged sheath was confirmed through complaint investigation.Visual analysis revealed that the sheath was kinked.Despite the damage, the sheath met all relevant dimensional requirements, and the dilator was able to pass through all areas of the sheath.Based on the customer report that the defect was found during use, the sample received, and past comments from packaging r & d, the root cause for this issue is storage/shipping related.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16897017
• Report Number: 9680794-2023-00326
• Device Sequence Number: 12340311
• Product Code: DQY
• UDI-Device Identifier: 10801902192483
• UDI-Public: 10801902192483
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN920047
• Device Catalogue Number: CL-07745
• Device Lot Number: 14F22B0202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown