MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SPRING WIRE GUIDE COMPONENT; WIRE GUIDE CATHETER

Model Number	IPN037337
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).No patient involvement was reported; however, the sample received showed signs of use.
Event or Problem Description
Customer reported "inner wire faulty.During removal of the guidewire from the wire holder, the inner wire came out".It was reported the issue was detected when pulling the guidewire out of the package.The device was replaced.
Additional Manufacturer Narrative
Qn#: (b)(4).The customer provided two photos for evaluation.The photos displayed a product packaging and a severely unraveled/separated guide wire.The customer also returned one product lidstock and guide wire.The guide wire was unraveled and the coils were separated in multiple pieces.Microscopic examination revealed the distal and proximal welds were both separated and not returned for evaluation.The total length of the returned core wire measured to be 191 mm which indicates at least 54 mm were separated and not returned per product drawing.The outer diameter of the guide wire measured to be 0.44 mm which is within specifications of 0.432-0.457 mm per product drawing.Functional inspection could not be performed due to the damage of the sample received.A manual tug test revealed the distal and proximal welds were separated.The coils were not secured to the core wire.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not apply excessive force in removing guide wire.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the customer report of a separated guide wire was confirmed by complaint investigation of the returned sample.The distal and proximal welds were broken and separated, and the coils were not secured to the core wire.A device history record review was performed with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.00 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
Customer reported "inner wire faulty.During removal of the guidewire from the wire holder, the inner wire came out".It was reported the issue was detected when pulling the guidewire out of the package.The device was replaced.

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11794454
• Report Number: 9680794-2021-00233
• Device Sequence Number: 1020581
• Product Code: DQX
• UDI-Device Identifier: 10801902128901
• UDI-Public: 10801902128901
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: No Information
• Device Expiration Date: 04/30/2025
• Device Model Number: IPN037337
• Device Catalogue Number: AW-04018
• Device Lot Number: 14F20D0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1