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

Model Number 39467-125

Device Problems Device Damaged by Another Device (2915); Output Problem (3005)

Patient Problem Perforation of Vessels (2135)

Event Date 10/23/2023

Event Type  Injury  

Event Description

It was reported that rotawire separation and perforation occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery (rca) segment 2.A rotawire drive and a 1.25mm rotapro were selected for use.The rotapro was prepped and platformed at 210,000 rpm outside the patient.During the procedure, non- boston scientific microcatheter was used, but it was unable to cross lesion.Then, the rotawire was delivered bare for the ablation with rotapro burr.After the rotawire and burr advanced, the rotation speed was adjusted, however, the rotation speed was at 180,000rpm and the speed did not increase.Therefore, re-adjustment as well as cocktail confirmation were performed.However, it was noted that the rotawire detached into two locations which were right before the rca segment 2, and y-shaped connector of the rotation speed adjustment, while the burr was on the wire.A non-boston scientific microcatheter was advanced into the body from the separation point for removal, however, the microcatheter came out at the coronary artery.It was noted a perforation at rca segment 2.The detached rotawire could not be removed from the patient.A bailout was performed with a non-boston scientific stent to suppress the perforation point and internal rotawire separation point.The physician's opinion as to the cause of the perforation was that the detachment occurred at rotation adjusting part, it took time to adjust the speed because rotation speed would not increase, so the possibility of spending time for speed adjustment could cause the detachment is not zero, but it is indeed unknown because the burr was not contact with the wire for long time.The physician has no idea what caused the detachment in the patient segment 2.The procedure was not completed due to this event.After the intra-aortic balloon pump was implanted, the patient was stable post procedure, and no further complications were reported.

Event Description

It was reported that rotawire separation and perforation occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery (rca) segment 2.A rotawire drive and a 1.25mm rotapro were selected for use.The rotapro was prepped and platformed at 210,000 rpm outside the patient.During the procedure, non- boston scientific microcatheter was used, but it was unable to cross lesion.Then, the rotawire was delivered bare for the ablation with rotapro burr.After the rotawire and burr advanced, the rotation speed was adjusted, however, the rotation speed was at 180,000rpm and the speed did not increase.Therefore, re-adjustment as well as cocktail confirmation were performed.However, it was noted that the rotawire detached into two locations which were right before the rca segment 2, and y-shaped connector of the rotation speed adjustment, while the burr was on the wire.A non-boston scientific microcatheter was advanced into the body from the separation point for removal, however, the microcatheter came out at the coronary artery.It was noted a perforation at rca segment 2.The detached rotawire could not be removed from the patient.A bailout was performed with a non-boston scientific stent to suppress the perforation point and internal rotawire separation point.The physician's opinion as to the cause of the perforation was that the detachment occurred at rotation adjusting part, it took time to adjust the speed because rotation speed would not increase, so the possibility of spending time for speed adjustment could cause the detachment is not zero, but it is indeed unknown because the burr was not contact with the wire for long time.The physician has no idea what caused the detachment in the patient segment 2.The procedure was not completed due to this event.After the intra-aortic balloon pump was implanted, the patient was stable post procedure, and no further complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the rotapro atherectomy system.The advancer, handshake connections, sheath, coil, and burr were visually and microscopically examined.Inspection of the device revealed that the annulus of the damaged.The damage to the annulus is consistent with interaction with the rotowire during rotation.Functional testing was performed by connecting the rotapro advancer to the rotapro console control system.When the knob switch [ablation button] was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.The burr annulus was damaged in a way consistent with interaction with the rotowire that could lead to a fracture.The reported speed issues were not able to be confirmed, as clinical circumstances were unable to be replicated and the device reached and maintained optimal rpm during analysis.No other issues were identified during the product analysis.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18107741
• MDR Text Key: 327864430
• Report Number: 2124215-2023-61184
• Device Sequence Number: 1
• Product Code: MCX
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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 Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0031651394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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
• Treatment: MICROCATHETER - ASAHI INTECC CORSAIR; MICROCATHETER - ASAHI INTECC CORSAIR; MICROCATHETER - TERUMO, ZIZAI; MICROCATHETER - TERUMO, ZIZAI; PK PAPYRUS STENT - BIOTRONIK AG; PK PAPYRUS STENT - BIOTRONIK AG
• Patient Outcome(s): Required Intervention