MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) ARROW-TREROTOLA PTD SET; CATHETER, EMBOLECTOMY

Catalog Number	PT-65509
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Trerotola device was used for thrombolysis of a dialysis fistula.Radio-opaque rubber tip (about 2x4mm) exited a defect in the fistula wall associated with recent dialysis punctures in a region of stenosis.The tip broke off into the soft tissues, confirmed fluoroscopically and upon device removal.Procedure was successfully completed with no immediate sequela.A stent was placed to treated the stenosis and tear, fully excluding the rubber tip from the fistula.Patient was informed.Fda safety report id# (b)(4).

• Brand Name: ARROW-TREROTOLA PTD SET
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 10501365
• Report Number: MW5096454
• Device Sequence Number: 19533944
• Product Code: DXE
• UDI-Device Identifier: 00801902013156
• UDI-Public: 0100801902013156
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20C0352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 101