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

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the burr became stuck on wire.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 1.25mm peripheral rotalink plus and a peripheral rotawire guidewire were selected for use.During withdrawal, the brake defeat button and the dynaglide button were depressed to back out the rotalink system over the rotawire.However, it was noted that the technician had a difficult time removing the rotalink burr over the rotawire.A wet sterile sponge was used and it became a little easier to remove the rotalink system back out over the rotawire.The rotawire and the rotalink system were removed simultaneously without any other complications.The procedure was completed without replacing the device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by manufacturer: returned product consisted of the peripheral rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device presented no damage or irregularities.In order to determine the functionality of the rotablator device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the rotablator device with no resistance or issues.Product analysis could not confirm the reported event, as the test wire was able to be fully inserted and removed with no resistance or issues, and there were no damages or defects attributable to a stuck rotawire identified during analysis.
Event or Problem Description
It was reported that the burr became stuck on wire.The 75% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 1.25mm peripheral rotalink plus and a peripheral rotawire guidewire were selected for use.During withdrawal, the brake defeat button and the dynaglide button were depressed to back out the rotalink system over the rotawire.However, it was noted that the technician had a difficult time removing the rotalink burr over the rotawire.A wet sterile sponge was used and it became a little easier to remove the rotalink system back out over the rotawire.The rotawire and the rotalink system were removed simultaneously without any other complications.The procedure was completed without replacing the device.No patient complications were reported.The device was returned for analysis and evaluation was completed on 20may2022.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device presented no damage or irregularities.In order to determine the functionality of the rotablator device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the rotablator device with no resistance or issues.Product analysis could not confirm the reported event, as the test wire was able to be fully inserted and removed with no resistance or issues, and there were no damages or defects attributable to a stuck rotawire identified during analysis.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14282016
• Report Number: 2134265-2022-05134
• Device Sequence Number: 17828371
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 08/06/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0027793345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown