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

Model Number 39467-215

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported an entrapment and detachment occurred.A 2.15 rotapro and rotawire drive were selected for use in an atherectomy procedure of the ostial right coronary artery (rca).The target lesion was severely tortuous and moderately calcified with 90% stenosis.During the rotation, the burr of the rotapro became entrapped with a previously placed unknown stent strut.Subsequently, the shaft of the rotapro and rotawire fractured and detached.A guide catheter was inserted and ballooned around the detached burr of the rotapro to snare the device for removal.The shaft, detached burr and fractured guidewire were successfully removed.There were no patient complications reported, and the patient was in stable condition post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the returned device consisted of the rotapro atherectomy system.The device was received with the burr separated.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil had been broken at the point of detachment from the burr.X-ray imaging of the burr found that the coil had terminated near the proximal end of the burr.The damage to the coil and the position of the break identified under x-ray imaging does not indicate a failure of the glue bond within the burr.The burr annulus was found to be damaged/not rounded.Product analysis confirmed the reported detached burr and broken shaft, as the burr was received detached from the coil, and the coil was broken at the point of detachment.The reported interaction with the stent strut could not be confirmed, as the stent material was not returned and clinical circumstances were unable to be replicated.

Event Description

It was reported an entrapment and detachment occurred.A 2.15 rotapro and rotawire drive were selected for use in an atherectomy procedure of the ostial right coronary artery (rca).The target lesion was severely tortuous and moderately calcified with 90% stenosis.During the rotation, the burr of the rotapro became entrapped with a previously placed unknown stent strut.Subsequently, the shaft of the rotapro and rotawire fractured and detached.A guide catheter was inserted and ballooned around the detached burr of the rotapro to snare the device for removal.The shaft, detached burr and fractured guidewire were successfully removed.There were no patient complications reported, and the patient was in stable condition post procedure.

Manufacturer Narrative

Corrected information: device code added to f10: device damaged by another device a0502.Device evaluated by manufacturer: the returned device consisted of the rotapro atherectomy system.The device was received with the burr separated.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the coil had been broken at the point of detachment from the burr.X-ray imaging of the burr found that the coil had terminated near the proximal end of the burr.The damage to the coil and the position of the break identified under x-ray imaging does not indicate a failure of the glue bond within the burr.The burr annulus was found to be damaged/not rounded.Product analysis confirmed the reported detached burr and broken shaft, as the burr was received detached from the coil, and the coil was broken at the point of detachment.The reported interaction with the stent strut could not be confirmed, as the stent material was not returned and clinical circumstances were unable to be replicated.

Event Description

It was reported an entrapment and detachment occurred.A 2.15 rotapro and rotawire drive were selected for use in an atherectomy procedure of the ostial right coronary artery (rca).The target lesion was severely tortuous and moderately calcified with 90% stenosis.During the rotation, the burr of the rotapro became entrapped with a previously placed unknown stent strut.Subsequently, the shaft of the rotapro and rotawire fractured and detached.A guide catheter was inserted and ballooned around the detached burr of the rotapro to snare the device for removal.The shaft, detached burr and fractured guidewire were successfully removed.There were no patient complications reported, and the patient was in stable condition post procedure.

• 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: 14111910
• MDR Text Key: 289266901
• Report Number: 2134265-2022-04193
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/10/2022

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: 12/20/2023
• Device Model Number: 39467-215
• Device Catalogue Number: 39467-215
• Device Lot Number: 0028586937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 04/27/2022; 06/08/2022
• Supplement Dates FDA Received: 05/13/2022; 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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
• Patient Outcome(s): Required Intervention