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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that burr detachment occurred.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified posterior tibial artery.A 1.25mm peripheral rotalink plus, a peripheral rotawire guidewire and a 2.5mm x 20mm x 143cm coyote es balloon were selected for use.During the priming/platforming of the rotalink, the physician noticed that the burr dislodged from the catheter.The burr was sitting on the wire detached from the tip of the catheter.They immediately discarded/put aside the whole setup including rotawire number one.They opened up a second rotalink and a second rotawire to continue with the procedure.The rotalink number two worked fine and was removed without any issues.They then opened a coyote balloon to post dilate the lesion but the balloon would not advance properly.Physician decided to remove the balloon and exchange the wire, the balloon was removed and intact.The physician used a rubicon/savion combination to buddy wire.Once the savion guidewire was in place, the physician removed the rotawire.However, rotawire number two upon removal, broke off by the distal tip.The break occurred when the wire was coming out of the sheath.The physician used fluoroscopy to see if any fragments were left behind.The dislodged tip was hanging on the sheath and was pulled out.They opened up another coyote balloon to complete the procedure.No complications were reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device revealed that the burr was detached from the coil and that the coil was fractured.The burr was not returned for analysis, so inspection of the burr was not able to be performed.Product analysis confirmed the reported event, as the burr was detached due to the coil being detached/broken.However, the burr was not returned for analysis, so it was not possible to inspect the burr for any irregularities or damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that burr detachment occurred.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified posterior tibial artery.A 1.25mm peripheral rotalink plus, a peripheral rotawire guidewire and a 2.5mm x 20mm x 143cm coyote es balloon were selected for use.During the priming/platforming of the rotalink, the physician noticed that the burr dislodged from the catheter.The burr was sitting on the wire detached from the tip of the catheter.They immediately discarded/put aside the whole setup including rotawire number one.They opened up a second rotalink and a second rotawire to continue with the procedure.The rotalink number two worked fine and was removed without any issues.They then opened a coyote balloon to post dilate the lesion but the balloon would not advance properly.Physician decided to remove the balloon and exchange the wire, the balloon was removed and intact.The physician used a rubicon/savion combination to buddy wire.Once the savion guidewire was in place, the physician removed the rotawire.However, rotawire number two upon removal, broke off by the distal tip.The break occurred when the wire was coming out of the sheath.The physician used fluoroscopy to see if any fragments were left behind.The dislodged tip was hanging on the sheath and was pulled out.They opened up another coyote balloon to complete the procedure.No complications were reported and the patient was fine post procedure.

• 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: 11617199
• Report Number: 2134265-2021-04119
• Device Sequence Number: 17234524
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 10/30/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026275931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR