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

Model Number	3241
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that burr separation occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink plus was selected for use and the burr became stuck within the lesion.During removal the burr became separated.Subsequently, inflation was performed at the proximal part and the burr was successfully retrieved via a snaring.The procedure was completed with non bsc device.No complications were reported.Patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath and coil were microscopically and visually examined.The coil is stretched and broken 11.5cm from the distal end of the burr catheter handshake connection.The detached/separated coil was returned along with the 156.4cm long broken rotawire.The other portion of the broken rotawire measuring 141.6cm long was returned with the detached burr on it.The burr was removed from the returned rotawire.The coil is stretched and kinked at the handshake connection.Microscopic examination of the detached burr revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The broken coil is visible in the proximal end of the burr.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that burr separation occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink plus was selected for use and the burr became stuck within the lesion.During removal the burr became separated.Subsequently, inflation was performed at the proximal part and the burr was successfully retrieved via a snaring.The procedure was completed with non bsc device.No complications were reported.Patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The burr catheter handshake connection was received still connected to the advancer handshake connection.The advancer, handshake connections, sheath and coil were microscopically and visually examined.The coil is stretched and broken 11.5cm from the distal end of the burr catheter handshake connection.The detached/separated coil was returned along with the 156.4cm long broken rotawire.The other portion of the broken rotawire measuring 141.6cm long was returned with the detached burr on it.The burr was removed from the returned rotawire.The coil is stretched and kinked at the handshake connection.Microscopic examination of the detached burr revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The broken coil is visible in the proximal end of the burr.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that burr separation occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink plus was selected for use and the burr became stuck within the lesion.During removal the burr became separated.Subsequently, inflation was performed at the proximal part and the burr was successfully retrieved via a snaring.The procedure was completed with non bsc device.No complications were reported.Patient was fine post procedure.It was further reported that the driveshaft was intentionally cut at its proximal side for retrieval of the detached rotational burr.An extension catheter was inserted from that section and removal was attempted.The rotawire was not separated during removal.Since the rotawire was intact, the detached burr was trapped with the spring tip of the rotawire and an snare catheter and the detached burr was retrieved successfully.

• 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: 8956610
• Report Number: 2134265-2019-10484
• Device Sequence Number: 2151120
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• 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,Followup
• Report Date (Section B): 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023011289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 11/07/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/14/2019; 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention