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

Model Number 39467-125

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Ischemia (1942); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2022

Event Type  Injury  

Event Description

It was reported that burr separation occurred.The diffused, 85% stenosed, concentric, de novo target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).A 1.25mm rotapro and rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.There was a significant bend in the lesion less than 45 degrees.Vascular access was obtained from the right femoral artery.An intra-aortic balloon pump (iabp) catheter was inserted into the left femoral artery, a non-boston scientific guiding catheter advanced and angiography performed on the rca.The lesion was predilated with a balloon.Seven ablations were performed with speeds between 155,000rpm and 166,000rpm and each run was under 30 seconds.After the seven ablations, the rotapro burr detached from the shaft and the devices were removed, including the detached burr, together with the rotawire.The procedure was completed with another 1.50mm rotapro device.There were no complications reported and the patient status was stable post procedure.

Manufacturer Narrative

Returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The rotawire used in the procedure was received within the device with the burr on the wire.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device found that the coil was stretched and broken, resulting in detachment of the burr.The annulus was also found to be damaged.During review of the device, it was found that the trifilar coil had broken.Further inspection performed using x-ray imaging found that the coils had separated within the burr, though no evidence of a glue bond failure was identified.Product analysis confirmed the reported events, as the device was received with a stretched and broken coil at the burr, resulting in burr detachment.

Event Description

It was reported that burr separation occurred.The diffused, 85% stenosed, concentric, de novo target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).A 1.25mm rotapro and rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.There was a significant bend in the lesion less than 45 degrees.Vascular access was obtained from the right femoral artery.An intra-aortic balloon pump (iabp) catheter was inserted into the left femoral artery, a non-boston scientific guiding catheter advanced and angiography performed on the rca.The lesion was predilated with a balloon.Seven ablations were performed with speeds between 155,000rpm and166,000rpm and each run was under 30 seconds.After the seven ablations, the rotapro burr detached from the shaft and the devices were removed, including the detached burr, together with the rotawire.The procedure was completed with another 1.50mm rotapro device.There were no complications reported and the patient status was stable post procedure.It was further reported that the patient presented with timi 2 flow and following use of the 1.50mm device, angiography revealed a dual lumen, consistent with dissection, at the site of the rota burr interaction with the vessel, with timi 1 distal flow.The procedure was continued with another 1.50mm rotapro device which initially met resistance in the proximal vessel.Four ablations were completed with speeds between 155,000rpm and 166,000rpm.The patient experienced bradycardia and hypotension.The rotawire was exchanged for a workhorse guidewire.Angiography revealed the dissection had expanded to form a pseudoaneurysm, no perforation, with timo 0 flow to the distal vessel.A 2.0mm balloon was inflated sequentially to improve flow.A 3.0 x 33 non-bsc drug eluting stent was implanted from proximal to mid vessel to provide flow to the mid rca.Final angiography showed a widely patent stent within a large, surrounding dissection plane (pseudoaneurysm).Flow was diminished past the mid vessel balloon inflations and barely reached the distal branches (timi 1).Dopamine was used to increase the patient blood pressure.There were no further patient complications and the patient status was stable.

Event Description

It was reported that burr separation occurred.The diffused, 85% stenosed, concentric, de novo target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).A 1.25mm rotapro and rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.There was a significant bend in the lesion less than 45 degrees.Vascular access was obtained from the right femoral artery.An intra-aortic balloon pump (iabp) catheter was inserted into the left femoral artery, a non-boston scientific guiding catheter advanced and angiography performed on the rca.The lesion was predilated with a balloon.Seven ablations were performed with speeds between 155,000rpm and 166,000rpm and each run was under 30 seconds.After the seven ablations, the rotapro burr detached from the shaft and the devices were removed, including the detached burr, together with the rotawire.The procedure was completed with another 1.50mm rotapro device.There were no complications reported and the patient status was stable post procedure.It was further reported that the patient presented with timi 2 flow and following use of the 1.50mm device, angiography revealed a dual lumen, consistent with dissection, at the site of the rota burr interaction with the vessel, with timi 1 distal flow.The procedure was continued with another 1.50mm rotapro device which initially met resistance in the proximal vessel.Four ablations were completed with speeds between 155,000rpm and 166,000rpm.The patient experienced bradycardia and hypotension.The rotawire was exchanged for a workhorse guidewire.Angiography revealed the dissection had expanded to form a pseudoaneurysm, no perforation, with timo 0 flow to the distal vessel.A 2.0mm balloon was inflated sequentially to improve flow.A 3.0 x 33 non-bsc drug eluting stent was implanted from proximal to mid vessel to provide flow to the mid rca.Final angiography showed a widely patent stent within a large, surrounding dissection plane (pseudoaneurysm).Flow was diminished past the mid vessel balloon inflations and barely reached the distal branches (timi 1).Dopamine was used to increase the patient blood pressure.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13485583
• MDR Text Key: 285339414
• Report Number: 2134265-2022-01246
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 03/10/2022

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: 10/05/2023
• Device Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0028142990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/16/2022; 03/09/2022
• Supplement Dates FDA Received: 03/01/2022; 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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
• Treatment: JR4 6F GUIDING CATHETER - MEDTRONIC; JR4 6F GUIDING CATHETER - MEDTRONIC; JR4 6F GUIDING CATHETER - MEDTRONIC; ROTAWIRE - BOSTON SCIENTIFIC; ROTAWIRE - BOSTON SCIENTIFIC; ROTAWIRE - BOSTON SCIENTIFIC
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Race: Asian