MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number	H802223300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of the event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as: mdr id: 2134265-2018-06425.It was reported that the wire broke off in front of the burr.A rotalink¿ plus and a rotawire floppy wire were selected for use for a patient procedure.The wire was placed inside of the patient.Then the burr was tested outside of the patient over the rotawire.While testing the rotational speed of 170rpm, the floppy wire that was distal to the tip of the burr simply broke off.The portion of the fractured wire, and the burr, were located outside of the patient's body.Therefore the distal portion of the wire that was inside of the patient was simply removed.A new wire and rotalink plus device were used to complete the procedure.No patient complications were reported.The patient's status was fine.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7673874
• Report Number: 2134265-2018-06426
• Device Sequence Number: 13664972
• Product Code: MCX
• UDI-Device Identifier: 08714729862277
• UDI-Public: 08714729862277
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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 Model Number: H802223300
• Device Catalogue Number: H802223300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1