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

Model Number	IPN036223
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported the physician "felt a kink and tried to pull the wire out and it began to unwind".No patient injury or harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer did not return a complaint sample; however, they supplied three photos showing a defective guide wire.The guide wire appears to be unraveled from the proximal tip and shows evidence of use, but it cannot be determined without the sample to evaluate.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "to minimize the risk of spring-wire guide damage withdraw catheter relative to spring-wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously".The report that the guide wire unraveled was confirmed through examination of the customer supplied photos.The images showed the guide wire unraveled; however, the actual complaint sample was not returned for evaluation.The device history records were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported the physician "felt a kink and tried to pull the wire out and it began to unwind".No patient injury or harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11543997
• Report Number: 9680794-2021-00122
• Device Sequence Number: 19967890
• Product Code: DYB
• UDI-Device Identifier: 10801902122466
• UDI-Public: 10801902122466
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K940079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: IPN036223
• Device Catalogue Number: AW-04225
• Device Lot Number: 14F21A0202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1