MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT; CATHETER, EMBOLECTOMY

Catalog Number PT-65709-WC

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The md was performing the procedure according to ifu.During the procedure, tip of the catheter was cut off.The md removed the tip safely and finished the procedure with new product.No intervention reported.

Event Description

The md was performing the procedure according to ifu.During the procedure, tip of the catheter was cut off.The md removed the tip safely and finished the procedure with new product.No intervention reported.

Manufacturer Narrative

(b)(4) the customer returned one 7fr ptd catheter for evaluation.Visual examination revealed the black pebax tip was partially separated and not returned.The orange inner lumen was also severely twisted protruding from the tip.R & d was contacted about this failure mode and stated that due to the damage observed with the orange lumen, a guidewire was likely not used during the procedure, which allowed the lumen to twist tightly.Once the tip broke, it allowed the orange lumen to twist up as seen with the returned sample.The remaining pebax tip measured to be 0.08" in length, which indicates that at least 0.51" was separated and not returned per product drawing.The ptd basket was able to advance and retract within the ptd sheath with significant resistance encountered at the twisted orange inner lumen.The ptd catheter was connected to a lab inventory rotator.When the button was depressed, the catheter rotated as expected.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "during native fistula de-clotting, it is strongly recommended that an appropriate guidewire should be used with the otw device.Excessive vessel tortuosity (i.E., tight stenosis alternate with broader segments of vessel or sharp angle of anastomosis) may significantly complicate the thrombectomy procedure.Due to tortuosity, if a guidewire cannot be advanced in the vessel or guidewire cannot cross the clot, then an alternative thrombectomy device or procedure should be explored." the customer report of a separated ptd tip was confirmed by complaint investigation of the returned sample.The pebax tip was separated and the orange inner lumen was severely twisted.R & d was consulted and indicated that a guidewire was likely not used during the procedure, which allowed the damage to occur to the orange lumen.A device history record review was performed with no relevant findings.Based on the customer report and the condition of the returned sample, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10245753
• MDR Text Key: 197970260
• Report Number: 9680794-2020-00297
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K011056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: PT-65709-WC
• Device Lot Number: 13F18K0432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1