MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC 2-LUMEN 5.5 FR X 55CM; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN038190
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the sheath was being used, sheath buckled and a new one had to be used to complete the procedure.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported the sheath was being used, sheath buckled and a new one had to be used to complete the procedure.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator/sheath assembly for evaluation.Signs of use in the form of biological material was observed on the sample.Visual examination of the assembly revealed the sheath body was damaged in two locations.The sheath body appeared deformed and folded in the locations of the damage.The damage on the sheath measured approximately 33mm and 50mm from the distal tip.The total length of the sheath body measured to be 2 7/8" which is within the specifications of 2 5/8" - 2 7/8" per product drawing.The outer diameter of the sheath body measured to be 0.1015" which is within specifications of 0.0960"-0.102" per product drawing.The inner diameter of the sheath body at the proximal end measured to be 0.081" which is within specifications of min.0.079" per product drawing.A lab inventory 5.5 fr catheter was inserted into the returned sheath per ifu which states, "advance soft tip/catheter tip as a unit through peel-away sheath to desired depth." despite the damage, the catheter was able to pass through the sheath with minimal resistance.The returned dilator was able to be inserted and locked with minimal resistance.Manufacturing was contacted regarding this complaint investigation.They performed a dimensional inspection report and a device history record review on the peel-away sheath extrusion, and found no evidence to suggest a manufacturing related issue.This indicates that the damage was likely caused by unintentional use error.A device history record review was performed, and no relevant findings were identified.The instructions for use (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 and bleeding".The customer report of a damaged sheath was confirmed by complaint investigation of the returned sample.A section of the sheath body was found to be deformed and folded in two locations.The sample passed all relevant dimensional inspection, and a device history record review was performed with no relevant findings.Based on the appearance of the damage, the customer report that the defect was observed during use, and the comments from r and d, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PICC 2-LUMEN 5.5 FR X 55CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 13804491
• Report Number: 9680794-2022-00174
• Device Sequence Number: 14710632
• Product Code: LJS
• UDI-Device Identifier: 10801902137422
• UDI-Public: 10801902137422
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• 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): 02/25/2022

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: 12/31/2022
• Device Model Number: IPN038190
• Device Catalogue Number: ASK-45552-LVH1
• Device Lot Number: 13F21K0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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
• Patient Sex: Unknown