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

Model Number	H749236310060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.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: 2134265-2018-05723.It was reported that the burr became stuck on the rotawire.The 90% stenosed target lesion was located in the moderately tortuous, severely calcified and 3.7mm in diameter proximal right coronary artery.A rotawire¿ and a 2.25mm rotalink¿ plus were selected for use.During the procedure, a 1.75mm burr was initially used due to the high stenosis rate and severe calcification.When the vessel diameter was measured by ivus, the size was 3.7mm; thus the burr was exchanged with a bigger size of 2.25mm.When the 2.25mm rotaburr was inserted into a non-bsc guide catheter, severe resistance was encountered.The physician attempted to further advance the burr through dynaglide mode; however, it was observed that the burr became stuck on the rotawire.The procedure was completed with a 2.15mm rotaburr and another of the same rotawire to ensure patient safety.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: 7638248
• Report Number: 2134265-2018-05718
• Device Sequence Number: 11318145
• Product Code: MCX
• UDI-Device Identifier: 08714729228394
• UDI-Public: 08714729228394
• 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): 06/07/2018

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 Expiration Date: 06/18/2019
• Device Model Number: H749236310060
• Device Catalogue Number: 23631-006
• Device Lot Number: 20899879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/26/2018
• 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: GUIDE CATHETER - 8F LAUNCHER JR4SH; INTRODUCER SHEATH- 8F RADIFOCUS