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

Model Number 3241

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 08/23/2018

Event Type  Injury  

Event Description

It was reported that patient condition was not good.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid of left circumflex (lcx) artery.A 1.25 mm rotalink plus and a rotawire were selected for use.During the procedure, a non bsc balloon was advanced through non bsc guide; however, failed due to severe calcification and tortuosity.Then, a rotawire was advanced with a rotaburr to ablate the lesion.However, it was noted that the patient condition was not good before the start of the procedure.No further patient complications were reported.The procedure was not completed.

Event Description

It was reported that patient condition was not good.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid of left circumflex (lcx) artery.A 1.25mm rotalink plus and a rotawire were selected for use.During the procedure, a non bsc balloon was advanced through non bsc guide; however, failed due to severe calcification and tortuosity.Then, a rotawire was advanced with a rotaburr to ablate the lesion.However, it was noted that the patient condition was not good before the start of the procedure.No further patient complications were reported.The procedure was not completed.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a rotablator rotalink plus device.The advancer unit and burr unit were received together.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.Microscopic examination of the device revealed that the coil is stretched.There were no abnormal noises or leaks and the device did not run; so it wasn't able to get any speed.The advancer was dismantled and the ultem was found to be melted.Product analysis confirmed the reported event due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• 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: 7833664
• MDR Text Key: 118788177
• Report Number: 2134265-2018-60501
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2019
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0020689872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER: RYUJIN PLUS1.5 * 15; BALLOON CATHETER: RYUJIN PLUS1.5 * 15; GUIDEWIRE: BMW; GUIDEWIRE: BMW; BALLOON CATHETER: RYUJIN PLUS1.5 * 15; GUIDEWIRE: BMW
• Patient Outcome(s): Other
• Patient Age: 77 YR