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

Model Number	3241
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire slipped behind the burr and fell back.The target lesion area was located in severely calcified left anterior descending artery (lad).A 2.00mm rotalink plus and rotawire were selected for use.During dynaglide mode, rotaburr worked normally.However, the rotawire moved out of the lad lesion and it was noted that it was slipping behind the rotalink plus and fell back during engagement of the rotaburr to the lesion while on dynaglide mode.The procedure was completed with another of the same device.No complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, brake, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device presented no damage or irregularities.The drive shaft was able to be rotated with no issues.So functional testing was performed by using a test rotawire and connecting the rotalink advancer to the rotablator control console system.The device was set-up per the ifu, and the advancer was able to reach optimum speed with no issues with the wire not moving when the brake was pushed.The device was then placed in dynaglide and there was still no issues or irregularities.Product analysis did not confirm the reported event, as there was no issues during functional testing; however, the brake is not designed to hold the guidewire firmly during dynaglide mode.
Event or Problem Description
It was reported that the wire slipped behind the burr and fell back.The target lesion area was located in severely calcified left anterior descending artery (lad).A 2.00mm rotalink plus and rotawire were selected for use.During dynaglide mode, rotaburr worked normally.However, the rotawire moved out of the lad lesion and it was noted that it was slipping behind the rotalink plus and fell back during engagement of the rotaburr to the lesion while on dynaglide mode.The procedure was completed with another of the same device.No complications reported.

• 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: 10515778
• Report Number: 2134265-2020-12451
• Device Sequence Number: 19444320
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/08/2020

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: 10/18/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024788535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR