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

Catalog Number	CL-07845
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "prior to the procedure according to ifu, the md discovered that the tip of the sheath was not smooth.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one sheath/dilator assembly and a portion of the product packaging for evaluation.Visual inspection of the sheath revealed several kinks and bends throughout the body, particularly near the distal tip.The dilator was removed from the assembly and observed to be bent in the same approximate locations as the kinks in the sheath.The returned portion of the product pouch showed significant creasing throughout.The damage appears consistent with defects caused by shipping and handling.The sheath body length from the hub to the distal tip measured 18 1/4" which is within the specification limits of 18 1/8"- 18 7/8" per product drawing.The sheath body outer diameter in an area that was not crushed measured 0.1395", which is within the specification limits of 0.136-0.140" per the sheath wrapped product drawing.The dilator was inserted through the proximal end of the sheath.The dilator met significant resistance at the kinked portion of the sheath but was able to pass through completely.Performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".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 customer re-port of a kinked sheath was confirmed through investigation of the returned sample.The sheath contained two major kinks which aligned with the creases/folds in the packaging.Despite this, the sheath passed all other relevant requirements.Therefore, based on the customer report and the sample received, shipping and storage likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "prior to the procedure according to ifu, the md discovered that the tip of the sheath was not smooth.".

• Brand Name: 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19699663
• Report Number: 9680794-2024-00701
• Device Sequence Number: 3641740
• Product Code: DQY
• UDI-Device Identifier: 00801902002006
• UDI-Public: 00801902002006
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/02/2024

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 Catalogue Number: CL-07845
• Device Lot Number: 14F22J0191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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