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

Model Number	3241
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: older than 18 years.The returned complaint device consisted of a rotalink burr catheter.The burr was detached and was on the returned rotawire that was in the burr catheter.The rotawire was removed with no issue and the burr was removed from the wire.The rotawire was not damaged.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The coil was stretched and broken 142cm from the strain relief.Microscopic examination of the device revealed that the annulus was damaged/fish-mouthed which is consistent with damage seen with the use of a rotawire.The broken coil was seen in the proximal end of the burr.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the drive shaft fractured.A 75% stenosed target lesion was located at the ostium part of the moderately tortuous and severely calcified proximal right coronary artery.A 1.75mm rotalink plus was selected for use.During the procedure, it was noted that there was difficulty engaging the 7f guide catheter.The 1.75 rotaburr was used for ablation four times during procedure at 200,000rpm.Then, it was removed and replaced by a 2.0 mm rotaburr.The 2.0mm rotaburr was also used for ablation four times at 200,000rpm.The physician then attempted to remove the rotaburr but the tip became stuck at the entrance of the guiding catheter.The rotaburr was pulled but it did not come out with the burr part on the tip.When pulling the wire, the burr entered inside the guiding catheter, so the entire system was removed together.The burr was confirmed to be separated after inspecting outside of the patient's body.The procedure was completed using balloon inflation and stent placement.There were no patient complications reported.

• 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: 8492064
• Report Number: 2134265-2019-03584
• Device Sequence Number: 11266437
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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: 08/17/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022660845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/08/2019
• 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: ROTAWIRE FLOPPY