MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 29720

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

It was reported that the burr was unable to retract over the wire. The target lesion was located in the severely calcified superficial femoral artery (sfa). A 2. 00mm peripheral rotalink plus and a peripheral rotawire were selected for use. During procedure, the burr stalled on two occasions. Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire. The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion. A new access was obtained and successful angioplasty was performed to complete procedure. There were no patient complications reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10875423
• MDR Text Key: 217336805
• Report Number: 2134265-2020-16161
• 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,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026074783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial