MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN030757
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the guidewire was unraveled during removal.There was no consequence for the patient, only an increase of the time of the intervention.
Event or Problem Description
It was reported the guidewire was unraveled during removal.There was no consequence for the patient, only an increase of the time of the intervention.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire and product lidstock for evaluation.The catheter was not returned for evaluation.Visual examination revealed the guide wire was unraveled from the proximal end.The fractured point of the core wire appeared discolored, which confirmed the wire broke adjacent to the weld.The guide wire also contained numerous kinks and bends along the body.The total length of the returned core wire measured to be 599 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the guide wire (measured in an undamaged location) measured to be 0.79 mm which is within specifications of 0.788-0.826 mm per product drawing.The returned guide wire was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." an undamaged portion of the returned guide wire was advanced through a lab inventory catheter with minimal resistance.A manual tug test confirmed that the distal weld was intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The ifu provided with this kit warns the user, "do not apply undue force on guidewire to reduce risk of possible breakage." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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)(4) 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 use error likely caused or contributed to this event.However, without the catheter to evaluate, the probable root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11845087
• Report Number: 3006425876-2021-00429
• Device Sequence Number: 3660954
• Product Code: DQY
• UDI-Device Identifier: 10801902028980
• UDI-Public: 10801902028980
• 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): 04/28/2021

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: 07/31/2024
• Device Model Number: IPN030757
• Device Catalogue Number: CS-12854-E
• Device Lot Number: 71F19L1121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1