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

Catalog Number	CL-07080
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: 03-nov-2023, the doctor found the catheter tip damaged prior to the patient.The returned device showed that the sheath was kinked.The complaint was changed to reportable.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a kinked sheath was confirmed through investigation of the returned sample.The customer returned one sheath, dilator and cath lab sheath packaging for analysis.No definite signs of use were observed.Visual analysis revealed that the sheath contained two major kinks along the body.The locations of the kinks aligned with folding of the cath lab kit packaging.The damage appears consistent with defects caused by shipping and handling.The sheath body length from the hub to the distal tip measured 31 1/4" via calibrated ruler, which was within the specification limits of 30 7/8" - 31 7/8" per the sheath ext with dilator product drawing.The sheath body outer diameter in an area that was not crushed measured 0.165" via calibrated caliper, which is within the specification limits of 0.163"-0.167" per the sheath wrapped product drawing.Functional inspection was performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".The dilator was inserted through the proximal end of the sheath.The dilator met significant resistance at the flattened portion of the sheath but was able to pass through completely.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." a device history record review was performed and no relevant findings were identified.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: on (b)(6) 2023, the doctor found the catheter tip damaged prior to the patient.The returned device showed that the sheath was kinked.The complaint was changed to reportable.

• Brand Name: ARRROW 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18587708
• Report Number: 9680794-2024-00091
• Device Sequence Number: 17900095
• Product Code: DQY
• UDI-Device Identifier: 00801902001733
• UDI-Public: 00801902001733
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: CL-07080
• Device Lot Number: 14F21D0128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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