MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	3241
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the base of the burr was detached.The 75% stenosed target lesion area was located in a severely tortuous and severely calcified proximal left circumflex (lcx) artery.A 2.15mm rotalink plus was selected for use.During procedure, the non-bsc stent which was placed in the circumflex artery from the left main trunk in the past was fractured in the tortuous part of the cx os.Subsequently, ablation was performed with this device upon restenosis case with severe calcification.Ablation time was 6 sessions for 15 seconds each, then poba was performed using a non-specified 2.0mm balloon catheter.Additionally, there were 9 sessions for 15 seconds each performed with this device.However, upon the ninth session, abnormal sound was heard.The knob of this device was manipulated but it was further noted that the burr did not moved as the rotational burr got detached from the driveshaft on the rotawire.The detached burr was then removed together with the rotawire under a guidezilla support since the wire was not broken.There were no device fragments left inside the patient's body.Also, the maximum burr rotational speed decrease at 15,000rpm during procedure and at 5,000rpm when the reported issue was noted.No patient complications were reported and the patient condition was good.
Event or Problem Description
It was reported that the base of the burr was detached.The 75% stenosed target lesion area was located in a severely tortuous and severely calcified proximal left circumflex (lcx) artery.A 2.15mm rotalink plus was selected for use.During procedure, the non-bsc stent which was placed in the circumflex artery from the left main trunk in the past was fractured in the tortuous part of the cx os.Subsequenlty, ablation was performed with this device upon restenosis case with severe calcification.Ablation time was 6 sessions for 15 seconds each, then poba was performed using a non-specified 2.0mm balloon catheter.Additionally, there were 9 sessions for 15 seconds each performed with this device.However, upon the ninth session, abnormal sound was heard.The knob of this device was manipulated but it was further noted that the burr did not moved as the rotational burr got detached from the driveshaft on the rotawire.The detached burr was then removed together with the rotawire under a guidezilla support since the wire was not broken.There were no device fragments left inside the patient's body.Also, the maximum burr rotational speed decrease at 15,000rpm during procedure and at 5,000rpm when the reported issue was noted.No patient complications were reported and the patient condition was good.
Additional Manufacturer Narrative
Device evaluated by the manufacturer.The device was returned for analysis.The advancer and handshake connection were visually examined.The burr was deteched from the burr catheter and returned on the rotawire.The coil of the burr catheter was stretched showing that force was applied prior to the burr detaching from the coil.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8808280
• Report Number: 2134265-2019-08483
• Device Sequence Number: 10842799
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: 08714729316473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/19/2019

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: 11/11/2019
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0021494787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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: CATHETER GUIDE EXTENSION - GUIDEZILLA; CATHETER GUIDE EXTENSION - GUIDEZILLA; STENT- ULTIMASTER, TERUMO; STENT- ULTIMASTER, TERUMO; CATHETER GUIDE EXTENSION - GUIDEZILLA; STENT- ULTIMASTER, TERUMO