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

Model Number	H749236310150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).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 operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-04741.It was reported that the burr became stuck on wire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 2.15mm rotalink¿ plus and rotawire¿ were selected for use.During procedure, after a non bsc guidewire was passed through the target lesion, the rotawire¿ was placed into the rca.The 2.15mm burr was then inserted and advanced; however, it failed to cross the lesion.The physician exchanged the burr with a smaller size and was used successfully to treat the lesion.The 2.15mm rotalink¿ plus was then advanced again but still failed to cross the lesion.When the device was withdrawn, resistance was encountered and the burr became stuck on the wire.The physician then removed it as a system and was not able to separate wire and the burr outside the patient¿s body.A non bsc balloon catheter was used to dilate the target lesion and the procedure was completed successfully.No patient complications were reported.

• 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: 6545386
• Report Number: 2134265-2017-04554
• Device Sequence Number: 16176487
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: (01)08714729316473(17)20180430(10)19315151
• 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): 04/18/2017

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: 04/30/2018
• Device Model Number: H749236310150
• Device Catalogue Number: 23631-015
• Device Lot Number: 19315151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER AVJ·MDT·JLL·KNK; GUIDE CATHETER TRM; GUIDE WIRE ASAHI INTEC; INFLATION DEVICE MDT; INTRODUCER SHEATH TRM