MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	H749236310150
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received attached together as a single unit.The advancer knob was received tightened a backward position.The advancer, coil, sheath, handshake connection, and burr were microscopically and visually examined.The annulus was damaged, flattened, and not round.The rotawire was not able to be inserted into the burr due to damaged annulus.The advancer and burr unit were detached and the wire was able to advancer through the advancer with no issues.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
Reportable based on device analysis of the related complaint completed on 31 march 2017.Same case as mdr id: 2134265-2017-03706.It was reported that resistance was encountered and the burr did not rotate.A 330cm rotawire¿ and a rotalink¿ plus were selected for use.During preparation, the burr had met resistance against the wire and it did not rotate due to friction.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis of the related complaint revealed that the rotawire was fractured.

• Brand Name: ROTALINK¿ PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6515792
• Report Number: 2134265-2017-03764
• Device Sequence Number: 16550964
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: (01)08714729316473(17)20180831(10)0019692119
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/31/2017

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: 08/31/2018
• Device Model Number: H749236310150
• Device Catalogue Number: 23631-015
• Device Lot Number: 0019692119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1