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 Problems Pain (1994); Insufficient Information (4580)

Event Date 03/04/2021

Event Type  Injury  

Event 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
• Type of Device: 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: 11569103
• MDR Text Key: 242265577
• Report Number: 2134265-2021-03739
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR