MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN914738
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the guide wire bent and could not be pulled out".No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the guide wire bent and could not be pulled out." no patient harm was reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire and introducer needle for analysis.Signs-of-use in the form of biological material was observed inside the needle hub.Visual analysis revealed that the guide wire was lodged inside the introducer needle.A kink was observed towards the distal end of the guide wire.Microscopic examination confirmed the kink and revealed that the distal and proximal welds were secure and intact.The guide wire was dislodged form the needle cannula and no defects or anomalies were observed.The kink on the guide wire measured 22mm from the distal weld.The guide wire total length measured 457mm which is within the specification limits of 450mm-458mm per the marked guide wire graphic.The guide wire outer diameter measured.62mm which is within the specification limits of.61mm-.635mm per the marked guide wire graphic.The cannula inner diameter at the distal and proximal end measured.027" which is within the specification limits of.027"-.0285" per the cannula graphic.The cannula outer diameter measured.0360" which is within the specification limits of.0355"-.0360" per the cannula graphic.After dislodging the guide wire from the cannula, the introducer needle was attached to a lab inventory arrow raulerson syringe (ars).The proximal end of the guide wire was then inserted through the subassembly.Little to no resistance was observed.Performed per ifu statement "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".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 findings were identified.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was kinked and stuck inside the introducer needle cannula.The guide wire was able to be dislodged with little to no difficulty.The guide wire and the cannula met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the guide wire bent and could not be pulled out".No patient harm was reported.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12333561
• Report Number: 3006425876-2021-00757
• Device Sequence Number: 2826119
• Product Code: DQY
• UDI-Device Identifier: 10801902157703
• UDI-Public: 10801902157703
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 07/30/2021

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: 10/22/2025
• Device Model Number: IPN914738
• Device Catalogue Number: CS-12702-E
• Device Lot Number: 71F20K1762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 09/16/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/15/2021; 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1