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

Model Number 29720

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10875423
• MDR Text Key: 217336805
• Report Number: 2134265-2020-16161
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (y/n): N
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR