MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN030863
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported the guidewire kinked in use.The consequence was a delay in treatment due to time to remove the device and insert another catheter.No other clinical consequence.No patient harm reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, unopened representative kit for analysis.No evidence that the kit was opened was observed.The kit was opened, and visual analysis did not reveal any defects or anomalies on the guide wire nor any other components.The guide wire total length measured 455mm which is within the specification limits of 450mm-458mm per the guide wire graphic.The guide wire outer diameter measured.790mm which is within the specification limits of.788mm-.826mm per the guide wire graphic.The guide wire was passed through the returned catheter and little to no resistance was observed.Performed per ifu statement "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire.Grasping near skin, advance catheter into vein with slight twisting motion".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant manufacturing issues were identified.The 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, bleeding, or component damage".The report of a kinked guide wire could not be confirmed through complaint investigation.The customer returned one, unopened representative kit for analysis.Visual analysis of the guide wire did not reveal any defects or anomalies.Additionally, the guide wire met all relevant dimensional and functional requirements , and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the guidewire kinked in use.The consequence was a delay in treatment due to time to remove the device and insert another catheter.No other clinical consequence.No patient harm reported.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12356132
• Report Number: 3006425876-2021-00792
• Device Sequence Number: 3245342
• Product Code: DQY
• UDI-Device Identifier: 10801902000559
• UDI-Public: 10801902000559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 10/31/2024
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F20A1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1