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

Model Number 3243

Device Problems Break (1069); Failure to Advance (2524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/08/2022

Event Type  Injury  

Event Description

It was reported that a device fracture occurred.A rotapro 1.50mm atherectomy catheter was selected for use.Rotational speed was 160.000 rpm.The rotapro burr failed to penetrate the lesion.After 3 attempts the drive shaft of the rotapro fractured.A balloon was carefully advanced and withdrawn to remove the fractured device.The rotapro was not completely detached.The procedure was cancelled and rescheduled for 2 months later.An additional device was required to retrieve the fractured rotapro.No patient harm resulted in relation to this event.The patient was stable post procedure.

Event Description

It was reported that a device fracture occurred.A rotapro 1.50mm atherectomy catheter was selected for use.Rotational speed was 160.000 rpm.The rotapro burr failed to penetrate the lesion.After 3 attempts the drive shaft of the rotapro fractured.A balloon was carefully advanced and withdrawn to remove the fractured device.The rotapro was not completely detached.The procedure was cancelled and rescheduled for 2 months later.It further reported that the burr head detached at the proximal fusion point of the shaft and the head.A 90% stenosed target lesion in the mildly tortuous and severely calcified proximal left anterior descending artery (lad).The minor deceleration indicator was visible during the procedure a few times.The burr was gradually moved only via the pecking method.The rotation speed set 160000rpm for the first three runs and the further three runs were done at 180000rpm.The burr detached 180000rpm.There were no patient complications, the patient was in a good condition post procedure, discharged and a new procedure planned.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The device was received with the burr separated.The rotawire used in the procedure was returned with the mach 1 catheter.A non-bsc balloon catheter was received with the device.The burr was received on the returned rotawire.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil had been stretched at the point of detachment from the burr.Functional testing was 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 was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.Product analysis confirmed the reported event, as the burr was received detached from the coil, and the coil was stretched at the point of detachment.The reported failure to ablate the lesion was not able to be confirmed, as the device was able to reach and maintain optimal rpm and the clinical circumstances were unable to be replicated.

Event Description

It was reported that a device fracture occurred.A rotapro (b)(4) atherectomy catheter was selected for use.Rotational speed was (b)(4).The rotapro burr failed to penetrate the lesion.After 3 attempts the drive shaft of the rotapro fractured.A balloon was carefully advanced and withdrawn to remove the fractured device.The rotapro was not completely detached.The procedure was cancelled and rescheduled for 2 months later.It further reported that the burr head detached at the proximal fusion point of the shaft and the head.A (b)(4) stenosed target lesion in the mildly tortuous and severely calcified proximal left anterior descending artery (lad).The minor deceleration indicator was visible during the procedure a few times.The burr was gradually moved only via the pecking method.The rotation speed set (b)(4) for the first three runs and the further three runs were done at (b)(4).The burr detached (b)(4).There were no patient complications, the patient was in a good condition post procedure, discharged and a new procedure planned.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15200438
• MDR Text Key: 297614640
• Report Number: 2124215-2022-29976
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup
• Report Date: 10/03/2022

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: 03/10/2024
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0029031358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/15/2022; 09/15/2022
• Supplement Dates FDA Received: 08/26/2022; 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male