MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX55CM W/130CM HYDR NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35552-HPHNL
Medical Device Problem Codes	Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "picc was being inserted in interventional radiology.Picc inserted through peel away sheath however when they were peeling sheath away, it broke and left part of it inside the patient's arm and they could not access it.As they were in ir, they ended up going femorally and removing the sheath and then the picc.A new picc was inserted without incident.Medical intervention: inserted catheter via femoral vein to approach sheath to hook it and remove it from vein.Another attempt at the procedure was successfully completed.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "picc was being inserted in interventional radiology.Picc inserted through peel away sheath however when they were peeling sheath away, it broke and left part of it inside the patient's arm and they could not access it.As they were in ir, they ended up going femorally and removing the sheath and then the picc.A new picc was inserted without incident.Medical intervention: inserted catheter via femoral vein to approach sheath to hook it and remove it from vein.Another attempt at the procedure was successfully completed.".

• Brand Name: ARROW PI PICC 2L 5FRX55CM W/130CM HYDR NIT SWG
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20084105
• Report Number: 9680794-2024-00812
• Device Sequence Number: 12715403
• Product Code: LJS
• UDI-Device Identifier: 00801902095602
• UDI-Public: (01)00801902095602(11)240314(17)251231(10)33F24A1616(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• 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): 07/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: PR-35552-HPHNL
• Device Lot Number: 33F24A1616
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown