MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Model Number	IPN033348
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "the patient was catheterized on the second attempt, and a guide wire was passed.Subsequently, a dilator was inserted, but it was not possible to advance it due to the tip of the dilator breaking open.Later, the patient experienced retraction, leading to the removal of the dilator".No patient injury was reported.The patient's current condition was reported to be critical.Additional information was requested but was not available at the time of this report.
Event or Problem Description
The complaint is reported as: "the patient was catheterized on the second attempt, and a guide wire was passed.Subsequently, a dilator was inserted, but it was not possible to advance it due to the tip of the dilator breaking open.Later, the patient experienced retraction, leading to the removal of the dilator." no patient injury was reported.The patient's current condition was reported to be critical.Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of damaged dilator tip was not able to be confirmed by visual inspection of the customer supplied photo.A full complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "do not withdraw dilator until the sheath is well within the vessel to minimize the risk of damage to sheath tip.Precaution: sufficient guide-wire length must remain exposed at hub end of sheath to maintain a firm grip on guidewire".A device history record review was performed, and no relevant findings were identified.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.

• Brand Name: ARROW PICC SET: 4 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 17174076
• Report Number: 9680794-2023-00426
• Device Sequence Number: 5642471
• Product Code: LJS
• UDI-Device Identifier: 00801902095312
• UDI-Public: 00801902095312
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (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): 05/24/2023

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: 07/31/2023
• Device Model Number: IPN033348
• Device Catalogue Number: PR-05041
• Device Lot Number: 14F21H0135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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 Age: 79 YR
• Patient Sex: Male