MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3243
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck on the guidewire.A 2.0mm rotapro catheter and a rotawire guidewire were selected for an atherectomy procedure.A 1.5mm device was initially used and then exchanged for the larger 2.0mm rotapro catheter.When attempting withdrawal of the rotawire from the coronary artery, the burr became stuck on the wire.The rotapro and rotawire were removed together from the patient.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a rotapro device.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The burr catheter was received attached to the advancer unit and a portion of the proximal end of the rotawire was returned inside of the device.The broken proximal end of the rotawire was removed from the device with no issue.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.The coil has become stretched due to manipulation during the procedure.A device to device interaction test was performed by inserting a test guidewire into the device and it was able to pass through.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr became stuck on the guidewire.A 2.0mm rotapro catheter and a rotawire guidewire were selected for an atherectomy procedure.A 1.5mm device was initially used and then exchanged for the larger 2.0mm rotapro catheter.When attempting withdrawal of the rotawire from the coronary artery, the burr became stuck on the wire.The rotapro and rotawire were removed together from the patient.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10122926
• Report Number: 2134265-2020-07528
• Device Sequence Number: 11357649
• Product Code: MCX
• UDI-Device Identifier: 08714729893387
• UDI-Public: 08714729893387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 08/27/2021
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0024340940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1