MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER CATHETER, PERIPHERAL, ATHERECTOMY

Model Number M0011373321

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

Same case as mdr id: 2134265-2017-13373 and 2134265-2017-13374. It was reported that foreign matter was observed on the rotawire and a rotawire fracture occurred. The target lesion was located in the anterior tibial artery of the right lower leg. A peripheral rotawire and a peripheral rotalink plus were selected for use. There were two rotawires that were pulled out from its hoop and white debris was observed at the proximal end. Subsequently, the second rotawire was used during platforming. When the physician loaded the rotaburr onto the rotawire, it was noted that the wire snapped in half. The rotawire was exchanged with another of the same device and the rotaburr was loaded onto it. However, the burr was unable to load onto the wire. The procedure was completed with another of the same rotaburr. No patient complications were reported and the patient's status was fine.

• Brand Name: PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7205522
• MDR Text Key: 97899416
• Report Number: 2134265-2018-00424
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M0011373321
• 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: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial