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	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: 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 has been determined to be use/user error as the dfu states: "recheck the rotational speed reading to verify that the rotation rate is appropriate for the burr size and lesion type, and adjust the operating speed; 2.15mm and larger burrs 140,000 up to 160,000 rpm.¿ (b)(4).
Event or Problem Description
It was reported that the burr became stuck in lesion.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).A 2.15mm rotalink¿ plus was selected to be used.Ablations were performed 180,000 rpm for 20 to 25 seconds each with the burr moving back and forth constantly.After the second ablation, a space in the lesion was noted and the burr became stuck on the space of the lesion.The outer sheath was removed and retrieval was successfully performed using a non bsc catheter without any patient injury.No further patient complications 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: 6285756
• Report Number: 2134265-2017-00184
• Device Sequence Number: 19063750
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: (01)08714729316473(17)20180831(10)0019692119.
• 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): 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: H749236310150
• Device Catalogue Number: 23631-015
• Device Lot Number: 0019692119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR