MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE; CATHETER, EMBOLECTOMY

Model Number PT-65509

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

Tip of percutaneous thrombolytic device broke of in arm av graft.The tip was removed.

• Brand Name: ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10441636
• MDR Text Key: 204015361
• Report Number: 10441636
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

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 Model Number: PT-65509
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F20E0204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1