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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: around (b)(6) years old.Device was evaluated by the manufacturer.The device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.There are numerous sheath kinks.The coil is stretched.The coil is separated 137.5cm from the strain relief.The detached burr was removed from the rotawire.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the rota burr detached off the rota catheter.The target lesion area was located in the anterior tibial artery.A 2.00mm peripheral rotalink plus was selected for an angiogram procedure.During the procedure, it was noted that the rotalink burr came off from the rota catheter and the burr was completely dislodged from the catheter while inside the patient's body.It was confirmed that no component of the device was left inside the patient's body.The rotawire distal tip has a larger diameter size than the rotablator burr, so the burr was removed upon removal of the rotawire.The procedure was completed with a different device.No complications reported and the patient was fine post procedure.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8906146
• Report Number: 2134265-2019-09915
• Device Sequence Number: 16826901
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0023128907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1