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

Model Number 3243

Device Problems Break (1069); Entrapment of Device (1212); Output Problem (3005)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported the device was broken and stuck in the lesion.The target lesion was located in a severely calcified the left main coronary artery (lm)/left anterior descending artery (lad).A 1.50mm rotapro was engaged in the target lesion.The target speed was 160,000rpm and the speed dropped to 40,000/50,000rpm.The device stalled and was stuck in the lad.It was noted the shaft of the device was broken.The burr was stalling sporadically prior to becoming stuck in the lad.The patient became hypotensive and the device was removed intact.The patient pressure stabilized and the patient recovered with no further treatment needed for the hypotension.The burr was replaced to continue.The patient was stable and discharged.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the burr housing, sheath, and portion of the coil used with a rotapro device.The rotapro advancer was not returned for analysis.The burr housing, sheath, returned portion of the coil, annulus, and burr were visually and microscopically examined.Visual examination and microscope inspection revealed that the device found that the coil and sheath had been separated at 26.5cm from the burr housing strain relief.The burr catheter handshake connection and remaining portion of the coil were not returned for analysis.Additional functional testing of the returned portion of the device was not able to be performed, as the burr catheter handshake connection is required to connect to a test advancer for functional testing, but was not returned for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported the device was broken and stuck in the lesion.The target lesion was located in a severely calcified the left main coronary artery (lm)/left anterior descending artery (lad).A 1.50mm rotapro was engaged in the target lesion.The target speed was 160,000rpm and the speed dropped to 40,000/50,000rpm.The device stalled and was stuck in the lad.It was noted the shaft of the device was broken.The burr was stalling sporadically prior to becoming stuck in the lad.The patient became hypotensive and the device was removed intact.The patient pressure stabilized and the patient recovered with no further treatment needed for the hypotension.The burr was replaced to continue.The patient was stable and discharged.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, 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: 14522065
• MDR Text Key: 292807882
• Report Number: 2134265-2022-05694
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0028737605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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): Other