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

Model Number 3241

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event 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 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.

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
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9843633
• MDR Text Key: 183876181
• Report Number: 2134265-2020-03343
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR