MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Model Number	IPN037697
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the peel away sheath tabs broke away from the sheath.The sheath was dislodged in the body requiring surgical intervention to removed." the patient's current condition was reported to be fine.
Event or Problem Description
It was reported "the peel away sheath tabs broke away from the sheath.The sheath was dislodged in the body requiring surgical intervention to removed." the patient's current condition was reported to be fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away catheter for analysis.Signs of use in the form of biological material were observed on the sheath tabs.Visual analysis revealed that both peel-away sheath tabs were separated from the extrusion.Despite this, a portion of the proximal end of the peel-away extrusion was still molded to both tabs.The point of separation occurred right at the distal end of the tabs.Microscopic examination confirmed the damage and revealed that the point of separation was stretched and folded.It was also noted that the score lines on the portion of the extrusions still molded on the tabs did not tear correctly.No obvious defects or anomalies were observed with the separated portion of the sheath extrusion.The sheath length from the point of separation to the distal tip measured 2 3/4", which is within the specification limits of 2 5/8"-2 7/8" per the catheter peel-away product drawing.The sheath outer diameter measured 0.0805", which is within the specification limits of 0.07800"-0.08400" per the catheter peel-away extrusion product drawing.The sheath inner diameter at the distal tip measured 0.064", which is within the specification limits of 0.064"-0.065" per the catheter peel-away product drawing.The sheath inner diameter at the proximal end (separated end) could not be accurately measured due to the nature of the separation.The separated portion of the peel-away extrusion was split down the score lines.Minor difficulty was initially encountered at the proximal end (separated end) due to the stretching; however, the sheath was eventually able to split completely down both score lines as intended.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated for batch 34c22c0033 to address the sheath not peeling correctly.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 vessel perforation and bleeding, or component damage".The ifu also states, "avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis".The report that the peel-away sheath tabs broke off during use was confirmed through complaint investigation of the returned sample.Visual analysis revealed that both sheath tabs separated from the extrusion.Despite this, a portion of the proximal end of the extrusion was still adhered to the separated tabs.The sheath met all relevant dimensional requirements.It was determined that the observed failure mode likely occurred during the manufacturing (molding) process.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE 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: 16616598
• Report Number: 9680794-2023-00213
• Device Sequence Number: 6272445
• Product Code: PND
• UDI-Device Identifier: 50801902130155
• UDI-Public: 50801902130155
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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
• Device Expiration Date: 01/31/2024
• Device Model Number: IPN037697
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 13F22H0390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/25/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown