MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5; CATHETER EMBOLECTOMY

Model Number	IPN035902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported "ptd basket wire(s) broke during the case at the tip of the catheter.No pieces were left in the patient".No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 5 fr catheter for evaluation.Visual inspection of the catheter revealed that the sheath had completely separated from the juncture hub.No remains of the sheath were found in the juncture hub.The sheath was fully covering the basket when returned.Microscopic examination revealed that the separation point on the sheath was deformed and twisted.Part of the wiring supporting the sheath was also exposed.The total length of the catheter body measured 23.4375", which is longer than the specifications of 22.9-23.1" per sheath extension assembly graphic, confirming that the sheath was pulled from inside the juncture hub molding as well.The outer diameter of the catheter body measured 0.07065", which is within specifications of 0.069-0.071" per sheath extension assembly graphic.The inner diameter of the catheter body measured 0.056", which is within specifications of 0.055-0.059" per sheath extension assembly graphic.The ptd catheter was not able to be functionally tested due to the damage on the catheter body.It was determined that the only way the failure was able to be recreated was through pulling directly on the sheath.The failure could not be recreated through normal process conditions.A device history record review was performed, and no relevant findings were identified.The complaint of a separated catheter was confirmed through a complaint investigation of the returned sample.The sheath of the ptd catheter was found to be completely separated from the juncture hub.The device met all dimensional requirements and a device history record review was performed, and no relevant findings were identified.Based on the device returned it was determined that user error - undue force likely caused this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "ptd basket wire(s) broke during the case at the tip of the catheter.No pieces were left in the patient".No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5
• Common Device Name: CATHETER EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11698363
• Report Number: 9680794-2021-00160
• Device Sequence Number: 3909490
• Product Code: DXE
• UDI-Device Identifier: 00801902013156
• UDI-Public: 00801902013156
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011056
• 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): 03/30/2021

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: 09/30/2022
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20K0630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1