MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 4.5FR X 7CM GLIDETHRU SHEATH/DILATOR; INTRODUCER CATHETER

Catalog Number	PL-00745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the peel-away sheath did not peel correctly.The sheath peeled part way and then the white handles broke away from the rest of the sheath that was around the picc.The clinician was able to use a hemostat and peel-away one side of the sheath to get it off of the indwelling line.The picc was completed without incident after removing the broken peel-away.No patient harm reported.The patient's condition is reported as fine.Additional information received states the inserter reported the white handle broke off immediately upon applying pressure.The handle separated from the body of the sheath before the sheath started "peeling apart".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of peel-away sheath tears incorrectly was able to be confirmed by the photo, however, based on the clarity of the photo, it is difficult to tell how the failure mode occurred.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and there was one potential finding.Two non-conformances were initiated for lot# 34c23f0030 in regard to "peel-away sheath tears incorrectly".Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same failure mode as the non-conformances identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding." the customer report of peel-away sheath tears incorrectly was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the peel-away sheath did not peel correctly.The sheath peeled part way and then the white handles broke away from the rest of the sheath that was around the picc.The clinician was able to use a hemostat and peel-away one side of the sheath to get it off of the indwelling line.The picc was completed without incident after removing the broken peel-away.No patient harm reported.The patient's condition is reported as fine.Additional information received states the inserter reported the white handle broke off immediately upon applying pressure.The handle separated from the body of the sheath before the sheath started "peeling apart".

• Brand Name: ARROW 4.5FR X 7CM GLIDETHRU SHEATH/DILATOR
• Common Device Name: INTRODUCER CATHETER
• 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: 17808625
• Report Number: 9680794-2023-00744
• Device Sequence Number: 6859181
• Product Code: DYB
• UDI-Device Identifier: 00801902080257
• UDI-Public: 00801902080257
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Expiration Date: 05/31/2025
• Device Catalogue Number: PL-00745
• Device Lot Number: 14F23E0261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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