MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number 3320

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.The target lesion was located in the heart.A 1.25mm rotalink burr was selected for use.During procedure, it was noted that the connector between the tail end of the burr and advancer was non-manually kinked.Furthermore, the rotawire could not enter into the advancer.The procedure was cancelled due to device issue.No patient complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Inspection of the device revealed that the coil was kinked at the handshake connection.The rotawire used in the procedure was not returned for analysis, so a test rotawire was used for functional testing.The wire was inserted through the annulus of the burr and advanced to the handshake connection; however, the wire was unable to pass the kinked coil.

Event Description

It was reported that the procedure was cancelled.The target lesion was located in the heart.A 1.25mm rotalink burr was selected for use.During procedure, it was noted that the connector between the tail end of the burr and advancer was non-manually kinked.Furthermore, the rotawire could not enter into the advancer.The procedure was cancelled due to device issue.No patient complications were reported and patient was stable post procedure.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10460653
• MDR Text Key: 204578880
• Report Number: 2134265-2020-11755
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024543651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 74