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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was unable to retract over the wire.The target lesion was located in the severely calcified superficial femoral artery (sfa).A 2.00mm peripheral rotalink plus and a peripheral rotawire were selected for use.During procedure, the burr stalled on two occasions.Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire.The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion.A new access was obtained and successful angioplasty was performed to complete procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator plus device with a guidewire inside of it.The burr catheter was attached to the advancer when received.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual and microscopic examination revealed no damages.Functional testing was performed by rotating the drive shaft and it was unable to rotate.The device was disassembled and the ultem was melted while the turbine is corroded.The guidewire was removed and analyzed under complaint (b)(4).Inspection of the remainder of the device presented no damage or irregularities.Product analysis found that the ultem is melted and the turbine is corroded.
Event or Problem Description
It was reported that the burr was unable to retract over the wire.The target lesion was located in the severely calcified superficial femoral artery (sfa).A 2.00mm peripheral rotalink plus and a peripheral rotawire were selected for use.During procedure, the burr stalled on two occasions.Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire.The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion.A new access was obtained and successful angioplasty was performed to complete procedure.There were no patient complications reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10875423
• Report Number: 2134265-2020-16161
• Device Sequence Number: 3766404
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 09/24/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026074783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR