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

Model Number	3320
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the rotalink burr catheter with the distal end of the related rota wire protruding out of the burr tip.Despite best efforts, the wire could not be dislodged from the rotalink burr.The protruding wire was observed to be stretched and bent.The handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection revealed the burr had evidence of being used in the procedure, handshake connector was bent, the coils were stretched and kinked, and the sheath was stretched, detached, and bent (excessive tensile applied to material).The housing was dismantled during the lab analysis.The rotalink advancer that was used in the procedure was not returned for analysis and testing the complaint device with a lab supplied advancer could not be completed, as the rotalink burr was too damaged to properly test.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated, and the damage/condition of the returned device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 09feb2021.It was reported that crossing difficulties were encountered.The 90% stenosed, 15mmx3.5mm target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the device could not cross the lesion.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed the distal end of the related rotawire was stuck and protruding out of the burr tip, the wire could not be dislodged from the rotalink burr, and sheath detachment.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11382347
• Report Number: 2134265-2021-02445
• Device Sequence Number: 19693752
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 12/22/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0025085219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/25/2021
• 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: ADVANCER - ROTALINK ADVANCER; GUIDEWIRE - 330CM ROTAWIRE
• Patient Age: 56 YR
• Patient Weight: 85