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

Model Number 39467-125

Device Problems Entrapment of Device (1212); Output Problem (3005); Program or Algorithm Execution Failure (4036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported that catheter and guidewire entrapment occurred.The 95% stenosed target lesion was in a moderately tortuous and severely calcified left anterior descending artery.A rotapro 1.25mm and rotawire drive were selected for treatment.Rotational speed was set to 200,000 rmp.The decel indicator came on.After ablation, there was resistance encountered during device removal.Dynaglide mode was not functioning at the time of removal.The rotapro 1.25mm and rotawire drive were stuck together.Both devices were removed together.No patient complications occurred as a result of the event.

Event Description

It was reported that catheter and guidewire entrapment occurred.The 95% stenosed target lesion was in a moderately tortuous and severely calcified left anterior descending artery.A rotapro 1.25mm and rotawire drive were selected for treatment.Rotational speed was set to 200,000 rmp.The decel indicator came on.After ablation, there was resistance encountered during device removal.Dynaglide mode was not functioning at the time of removal.The rotapro 1.25mm and rotawire drive were stuck together.Both devices were removed together.No patient complications occurred as a result of the event.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.The returned wire was able to be removed with no resistance or issues.The advancer, handshake connections, sheath, coil, burr, and annulus were visually and microscopically examined.Visual and microscope inspection revealed that the device presented with no damage or irregularities.The returned rotawire was able to be inserted into the burr and advanced through the advancer with no resistance or issues.Functional testing was then performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the advancer was able to reach and maintain optimal rpm with no resistance or issues.When the dynaglide mode change button was pressed, the advancer was able to reach and maintain optimal rpm in dynaglide mode with no resistance or issues.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that catheter and guidewire entrapment occurred.The 95% stenosed target lesion was in a moderately tortuous and severely calcified left anterior descending artery.A rotapro 1.25mm and rotawire drive were selected for treatment.Rotational speed was set to 200,000 rmp.The decel indicator came on.After ablation, there was resistance encountered during device removal.Dynaglide mode was not functioning at the time of removal.The the rotapro 1.25mm and rotawire drive were stuck together.Both devices were removed together.No patient complications occurred as a result of the event.

• 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 SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13544289
• MDR Text Key: 285746414
• Report Number: 2134265-2022-01754
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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: 08/20/2023
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0027879153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• 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