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 Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that burr stuck in lesion and open surgery was performed.The target lesion was located in the moderately calcified right posterior tibial artery.A 1.50mm peripheral rotalink plus was selected for use.During procedure, the burr was advanced however it stalled and the patient was in pain.The device was then removed but it only came back at about 3-4cm before getting stuck.Attempts were made to remove the device by using dynaglide, manually pulling back.They even cut the burr off the advancer and used 6fr guide catheter to dislodge the burr from the vessel wall but was unsuccessful.The procedure was then stopped, patient was transferred to the nearby hospital and had an open surgery.The burr was removed and there were perforation seen as it was surrounded by the intimal wall and the patient was doing well post operation.No further 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: 11569103
• Report Number: 2134265-2021-03739
• Device Sequence Number: 4455401
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026414410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR