MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW-TREROTOLA PTD; CATHETER, EMBOLECTOMY

Lot Number 13F18L0773

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombus (2101)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

Procedure:right upper extremity arteriovenous fistula declot arrow trerolola percutaneous device utilized for declot tip of device retained in patient due to device failure no adverse effects for patient, no additional procedures required.Patient was found to have chronic occlusion of the proximal right innominate vein with thrombus present in the mid/distal right innominate vein.Initial reconstruction attempts did yield a small patent channel through the area with central flow restored.During this portion of the procedure, a small distal portion of the mechanical thrombectomy device sheared off within the area of the chronic occlusion and embedded within the vessel wall.This was disclosed to the patient and has no clinical sequelae.

• Brand Name: ARROW-TREROTOLA PTD
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TELEFLEX INCORPORATED; 6550 wedgwood rd. n.; suite 300; maple grove MN 55311
• MDR Report Key: 8431572
• MDR Text Key: 139225759
• Report Number: 8431572
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 13F18L0773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Date Report to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 29