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

Model Number	3241
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that burr to handshake connection was broken.A 2.00mm rotalink plus was selected for use.During preparation, the advancer knob seemed to be hard to move.Upon advancing the wire through the burr tip, the wire got stuck in the burr tip and could not advance any further.When the device was removed, a break was noted between the end of the burr tip about 2cm before the handshake connection.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that burr to handshake connection was broken.A 2.00mm rotalink plus was selected for use.During preparation, the advancer knob seemed to be hard to move.Upon advancing the wire through the burr tip, the wire got stuck in the burr tip and could not advance any further.When the device was removed, a break was noted between the end of the burr tip about 2cm before the handshake connection.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer.The device was returned for analysis.The returned complaint device consisted of a rotablator plus device.The burr catheter was not attached to the advancer when received.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed that the coil is separated at the handshake connection.The burr catheter handshake connection is still attached for the advancers handshake connection.The separated coil is 7.5cm from the proximal end of the sheath and stretched.Microscopic examination revealed scratches to the proximal end of the sheath at the separation.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported separation which would cause difficulty to load wire and difficulty to use advancer knob.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9843633
• Report Number: 2134265-2020-03343
• Device Sequence Number: 2421616
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 05/28/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024030478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR