MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Codes	Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "the peel-away sheath could not be inserted into the blood vessel." additional information reports, "it is too soft to be inserted smoothly." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the peel-away sheath could not be inserted into the blood vessel." additional information reports, "it is too soft to be inserted smoothly." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one peel-away sheath with dilator assembly for analysis.Signs of use were observed on the sheath and dilator.Visual analysis revealed that the distal end of the sheath tip was damaged.Slight bending was noted across the peel-away/dilator body.Also, a small scratch mark was noted on the dilator directly adjacent to the sheath tip.The sheath length from the tabs to the distal tip measured 4.0157", which is within the specification limits of 3.875"-4.125" per peel-away product drawing.The sheath outer diameter measured 0.076", which is within the specification limits of 0.075"-0.081" per peel-away product drawing.The sheath inner diameter at the distal tip could not be accurately measured due to the nature of the damage.The peel-away sheath and dilator were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "ensure dilator is in position and locked to hub of sheath".The dilator was removed, reinserted back into the sheath, and locked into the sheath hub.The dilator was able to pass through the sheath tip with little to no resistance.R & d and manufacturing were previously consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.A device history record review was performed, and relevant findings were identified.Five non-conformances were initiated to address various failures involved with the peel-away sheath.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage".The report of peel-away body damage was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was damaged.Despite the damage, the sheath and the dilator met all relevant functional requirements.Various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user, therefore, the root cause is undetermined.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO 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: 20321385
• Report Number: 9680794-2024-01020
• Device Sequence Number: 8006273
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: (01)00801902101051(11)231018(17)250731(10)33F23J0679(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 33F23J0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown