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

Model Number 3241

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Event Description

It was reported that a shaft separation occurred.The target lesion area was located in the severely tortuous and severely calcified left main trunk to left circumflex coronary artery.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that the drive shaft became separated inside the non-bsc 7f guiding catheter.Consequently, the guidewire was passed through the guiding catheter.Then, it was trapped by a 2.00mm balloon in the distal and removed together with the system.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable post-procedure.

Event Description

It was reported that a shaft separation occurred.The target lesion area was located in the severely tortuous and severely calcified left main trunk to left circumflex coronary artery.A 1.25mm rotalink plus was selected for use.During the procedure, it was noted that the drive shaft became separated inside the non-bsc 7f guiding catheter.Consequently, the guidewire was passed through the guiding catheter.Then, it was trapped by a 2.00mm balloon in the distal and removed together with the system.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable post-procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The burr catheter was received attached to the advancer unit.The detached burr was not received with the advancer.The separated burr was returned with the rotawire.The advancer, handshake connections, sheath and coil were microscopically and visually examined.The coil was stretched and broken 135cm from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9161967
• MDR Text Key: 161857307
• Report Number: 2134265-2019-12057
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 03/03/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023584288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/27/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 7F EBU 3.5; GUIDE CATHETER: 7F EBU 3.5