MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK PERIPHERAL ROTALINK® PLUS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	M0011401500
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was not returned for analysis.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
It was reported that the burr caught the drape.A peripheral rotalink® plus was selected for use.During preparation outside patient's body, the rotation of the device was tested.The device moved as the physician tested the rpms.Consequently, it was noticed that the burr became caught on the blue table drape and the foreign material wrapped around the burr.The device did not enter the patient's body.No patient complications were reported.

• Brand Name: PERIPHERAL ROTALINK® PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6602301
• Report Number: 2134265-2017-05266
• Device Sequence Number: 19149139
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: (01)08714729838906(17)20181130(10)20003891
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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: 11/30/2018
• Device Model Number: M0011401500
• Device Lot Number: 20003891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1