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	07/13/2017
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: 2134265-2017-07649.It was reported that the burr became stuck on the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 2.15 mm rotalink¿ plus and rotawire were selected for use.During procedure, it was noted that the advancer was unable to be advanced upon delivery.The device was removed outside patient's body and noted that the burr became stuck on the rotawire.The physician was able to separate the burr from the rotawire.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the procedure was completed with the same burr catheter and another of the same rotawire.

• 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: 6767276
• Report Number: 2134265-2017-07600
• Device Sequence Number: 13956515
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: (01)08714729316473(17)20180630(10)0019533227
• 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,Followup
• Report Date (Section B): 07/14/2017

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: 06/30/2018
• Device Model Number: H749236310150
• Device Catalogue Number: 23631-015
• Device Lot Number: 0019533227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1