MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030108
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the spring wire guide unraveled when pulling it out.No patient injury or complication reported.The device was replaced.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire for evaluation.Signs-of-use in the form of biological material was observed on the guide wire body.Visual analysis revealed that the guide wire was unraveled from the distal end.The guide wire body also contained several gradual bends.Microscopic examination confirmed the damage and revealed that distal weld had separated from the core wire but was still attached to the coil wire.Both welds appeared to be spherical.The guide wire length from the proximal weld to the point of separation measured 601mm , which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.84mm, which is within the specification limits of.838mm-.877mm per the guide wire graphic.The proximal end of the guide wire was inserted through a lab inventory introducer needle/ars (inserted up until unraveled section).The guide wire was able to pass with little to no resistance.A manual tug test revealed that the proximal weld was 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 apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".The ifu also states, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide".The report of an unraveled guide wire was confirmed through complaint investigation of the returned sample.Visual examination revealed that the distal weld had separated from the core wire but was still attached to the coils.This caused the guide wire to unravel from the distal end.The damage was consistent with undue force being applied to the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso (b)(6) standard of 2.2 pounds force for this size wire.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: the spring wire guide unraveled when pulling it out.No patient injury or complication reported.The device was replaced.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11247786
• Report Number: 3006425876-2021-00086
• Device Sequence Number: 3649072
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: 00801902102188
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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): 01/12/2021

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: 04/07/2022
• Device Model Number: IPN030108
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F20E1820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1