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

Model Number	3241
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the burr was stuck with the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink plus and a rotawire were selected for use.During the procedure, it was noted that the burr was stuck with the rotawire.When the burr was tried to be removed, it did not come out and became unable to be pulled.The rotalink was pulled out together with the rotawire without difficulty and the procedure was completed with the original device.After removing the devices from the patient, the rotawire was removed from the rotalink burr.There might be resistance when pulling the rotawire out from the rotalink.No complications were reported and the patient was discharged without any problem.
Event or Problem Description
It was reported that the burr was stuck with the rotawire.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm rotalink plus and a rotawire were selected for use.During the procedure, it was noted that the burr was stuck with the rotawire.When the burr was tried to be removed, it did not come out and became unable to be pulled.The rotalink was pulled out together with the rotawire without difficulty and the procedure was completed with the original device.After removing the devices from the patient, the rotawire was removed from the rotalink burr.There might be resistance when pulling the rotawire out from the rotalink.No complications were reported and the patient was discharged without any problem.It was further reported that no fragments were remained in the patient.The patient was already discharged from the hospital without any health injury.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device presented no damage or irregularities.The rotawire used in the procedure was returned inside of the rotablator device.Functional testing consisted of attempting to remove the rotawire from the rotablator device.The wire was able to be removed from the device was no resistance or issues.No issues were identified during the product analysis.

• 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: 10593428
• Report Number: 2134265-2020-13364
• Device Sequence Number: 3735366
• 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,Followup
• Report Date (Section B): 11/10/2020

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: 11/15/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024939739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1