MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN039803
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported during insertion, the smartseal introducer and dilator broke entirely.Both pieces were retrieved from the patient with a snare.The patient was reported to be fine.No injury or consequence reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one merit medical dilator for analysis.Signs of use were observed on the dilator body.Visual inspection of the sample confirmed the dilator was separated in two locations.One separation was towards the distal tip and the other separation was in the middle of the extrusion.The other end of the separated half (hub end) was not returned for analysis.The first separation in the dilator measured 11mm from the distal tip.The second separation measured approximately 80mm from the distal tip.The total length of the returned sections of the dilator measured.433" and 2.716" , totaling 3.149", which indicates that at least 5.340" of the dilator body was severed and not returned for analysis.The outer diameter of the dilator measured 0.210" which is within specifications of 0.209-0.212" per sheath/dilator product drawing.The inner diameter at dilator tip measured 0.038" which is within specifications of 0.038-0.039" per sheath/dilator product drawing.A device history record review was performed, and a relevant finding was identified.Three non-conformances were initiated for batch 13p20f0245 to address the issue of a defective dilator tip.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The complaint of a separated dilator body was confirmed by a complaint investigation of the returned sample and the customer photo.The dilator was separated in two locations.One separation was located towards the distal tip, while the second separation occurred around the middle of the extrusion.A device history record review was performed, and a relevant finding was identified.Based on the customer report and the sample returned, the root cause of this investigation is supplier related.A non-conformance was initiated to address the issue involved with this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported during insertion, the smartseal introducer and dilator broke entirely.Both pieces were retrieved from the patient with a snare.The patient was reported to be fine.No injury or consequence reported.

• Brand Name: HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13258745
• Report Number: 9680794-2022-00058
• Device Sequence Number: 4663336
• Product Code: MSD
• UDI-Device Identifier: 10801902145809
• UDI-Public: 10801902145809
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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
• Device Expiration Date: 07/31/2023
• Device Model Number: IPN039803
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 13F20G0625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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
• Patient Sex: Unknown