MAUDE Adverse Event Report: COVIDIEN IRVINE BTK TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gangrene (1873)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date. If information is provided in the future, a supplemental report will be issued.

Event Description

Journal of vascular and interventional radiology this article was written to evaluate the efficacy of peripheral atherectomy device is tasc type c and d femoropopiliteal lesions. The article reports that femoral access was taken and occlusion was crossed using hydrophilic 0. 035¿ guide-wire non-mdt in 8 patients and using 0. 014¿ wire (nitrex, medtronic) in 3 patients. The 0. 035¿ wire was exchanged with 0. 014¿ wire and directional atherectomy device (turbohawk, medtronic) was then used. A distal embolic protection device was not used. Post atherectomy angiogram was taken, followed by dcb angioplasty (medtronic). Digital amputation was reported in 5 patients who had presented with gangrene.

• Brand Name: BTK TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7517796
• MDR Text Key: 108358707
• Report Number: 2183870-2018-00275
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K111723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/16/2018 Patient Sequence Number: 1