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

Model Number 39467-150

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that stent damage post deployment with secondary device interaction occurred.A percutaneous coronary intervention (pci) with a right transradial intervention (tri) approach was performed on a 99% stenosed, moderately tortuous, and severely calcified mid to distal right coronary artery (rca).A 0.014 wire and a microcatheter were advanced, but neither were able to cross the lesion.A rotawire drive extra support was able to cross in bare.To allow for rotablation, a 3.50 x 20mm synergy xd was first placed in the mid rca due to the inability of the microcatheter crossing the distal part of the lesion.It was noted that the stent was well apposed to the vessel wall.Post dilation was not performed.Intravascular ultrasound (ivus) was unable to confirm placement of the stent.Following placement of the stent, a 1.5mm rotapro was selected to perform rotablation.While starting ablation, the distal edge of the synergy xd previously placed was noted to have become entangled in the mid rca.It was clarified that the synergy xd had become entangled on the burr.While pulling the burr, the stent was also pulled, and became stuck in the mid rca.The burr and the stent became stuck in the mid rca while pulling the devices from the patient.The base of the drive shaft was detached, and the device was removed up to the proximal rca.Following an attempt to remove the device again with a 7f guideliner, the device became caught due to a stent noted to have entangled around the middle of the radius and elbow.The drive shaft was detached.It was clarified that to remove the device, the shaft was cut at the root.The sheath was changed from a 6f to an 8f, and the device was removed.Following removal of the device, imaging was performed and revealed that the 4.0 x 15 non boston scientific stent previously placed in the proximal rca could not be confirmed.The synergy xd had not remained implanted, and was removed from the patient, while entangled in the burr.It was noted that there was a possibility that the stent had entangled at the same time when the other entangled stent was removed.It was clarified that the rotapro, synergy xd stent, and the non boston scientific stent were removed from the patient.It was noted that it was suspected that these three devices were within the entangled extraction.The procedure was not completed due to this event as the target treatment could not be completed.No patient complications were reported in relation to this event.

Event Description

It was reported that stent damage post deployment with secondary device interaction occurred.A percutaneous coronary intervention (pci) with a right transradial intervention (tri) approach was performed on a 99% stenosed, moderately tortuous, and severely calcified mid to distal right coronary artery (rca).A 0.014 wire and a microcatheter were advanced, but neither were able to cross the lesion.A rotawire drive extra support was able to cross in bare.To allow for rotablation, a 3.50 x 20mm synergy xd was first placed in the mid rca due to the inability of the microcatheter crossing the distal part of the lesion.It was noted that the stent was well apposed to the vessel wall.Post dilation was not performed.Intravascular ultrasound (ivus) was unable to confirm placement of the stent.Following placement of the stent, a 1.5mm rotapro was selected to perform rotablation.While starting ablation, the distal edge of the synergy xd previously placed was noted to have become entangled in the mid rca.It was clarified that the synergy xd had become entangled on the burr.While pulling the burr, the stent was also pulled, and became stuck in the mid rca.The burr and the stent became stuck in the mid rca while pulling the devices from the patient.The base of the drive shaft was detached, and the device was removed up to the proximal rca.Following an attempt to remove the device again with a 7f guideliner, the device became caught due to a stent noted to have entangled around the middle of the radius and elbow.The drive shaft was detached.It was clarified that to remove the device, the shaft was cut at the root.The sheath was changed from a 6f to an 8f, and the device was removed.Following removal of the device, imaging was performed and revealed that the 4.0 x 15 non boston scientific stent previously placed in the proximal rca could not be confirmed.The synergy xd had not remained implanted, and was removed from the patient, while entangled in the burr.It was noted that there was a possibility that the stent had entangled at the same time when the other entangled stent was removed.It was clarified that the rotapro, synergy xd stent, and the non boston scientific stent were removed from the patient.It was noted that it was suspected that these three devices were within the entangled extraction.The procedure was not completed due to this event as the target treatment could not be completed.No patient complications were reported in relation to this event.It was further reported that the rotawire was placed in the vessel after the 3.50 x 20mm synergy xd was deployed.Vascular dissection was suspected in the rca 1 and 2, but no treatment was performed.No additional intervention was performed, and the procedure was aborted due to the radiation was over 12 grays.No further patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

Manufacturer Narrative

E1: initial reporter address - (b)(6).

Manufacturer Narrative

E1: initial reporter address - (b)(6).Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.A majority of the burr catheter was not received for analysis in accordance with the reported events.A separate container of liquid was received, it was considered likely that this container of liquid was used to store the stent and tissue-like material from the related complaint.The advancer, handshake connections, housing, sheath, coil, and burr were visually examined.Inspection of the device found that the coil and sheath had been severed 10cm distal of the burr handshake connection.The distal portion of the coil and burr was measured and found to be 4cm in length.The returned ends of the coil were found to be kinked, stretched, and broken.A portion of the rotawire used in the procedure was found returned within the distal portion of the burr catheter.The advancer handshake connection was also found to be bent.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to rotate.When the rotapro advancer was connected to the rotapro console control system and the ablation button [knob switch] was pressed, the advancer stalled and would not run due to the bent handshake connection.Product analysis confirmed the reported events, as the previous analysis of the device through the related confirmed the presence of two stent structures attached to the burr catheter, and analysis of the returned portions of the device found that the sheath, coil, and rotawire had been separated in accordance with the reported difficulties removing the burr and resulting additional intervention.

Event Description

It was reported that stent damage post deployment with secondary device interaction occurred.A percutaneous coronary intervention (pci) with a right transradial intervention (tri) approach was performed on a 99% stenosed, moderately tortuous, and severely calcified mid to distal right coronary artery (rca).A 0.014 wire and a microcatheter were advanced, but neither were able to cross the lesion.A rotawire drive extra support was able to cross in bare.To allow for rotablation, a 3.50 x 20mm synergy xd was first placed in the mid rca due to the inability of the microcatheter crossing the distal part of the lesion.It was noted that the stent was well apposed to the vessel wall.Post dilation was not performed.Intravascular ultrasound (ivus) was unable to confirm placement of the stent.Following placement of the stent, a 1.5mm rotapro was selected to perform rotablation.While starting ablation, the distal edge of the synergy xd previously placed was noted to have become entangled in the mid rca.It was clarified that the synergy xd had become entangled on the burr.While pulling the burr, the stent was also pulled, and became stuck in the mid rca.The burr and the stent became stuck in the mid rca while pulling the devices from the patient.The base of the drive shaft was detached, and the device was removed up to the proximal rca.Following an attempt to remove the device again with a 7f guideliner, the device became caught due to a stent noted to have entangled around the middle of the radius and elbow.The drive shaft was detached.It was clarified that to remove the device, the shaft was cut at the root.The sheath was changed from a 6f to an 8f, and the device was removed.Following removal of the device, imaging was performed and revealed that the 4.0 x 15 non boston scientific stent previously placed in the proximal rca could not be confirmed.The synergy xd had not remained implanted, and was removed from the patient, while entangled in the burr.It was noted that there was a possibility that the stent had entangled at the same time when the other entangled stent was removed.It was clarified that the rotapro, synergy xd stent, and the non boston scientific stent were removed from the patient.It was noted that it was suspected that these three devices were within the entangled extraction.The procedure was not completed due to this event as the target treatment could not be completed.No patient complications were reported in relation to this event.It was further reported that the rotawire was placed in the vessel after the 3.50 x 20mm synergy xd was deployed.Vascular dissection was suspected in the rca 1 and 2, but no treatment was performed.No additional intervention was performed, and the procedure was aborted due to the radiation was over 12 grays.No further patient complications resulted in relation to this event and the patient was reported to be stable following the 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 IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12737216
• MDR Text Key: 279586845
• Report Number: 2134265-2021-13754
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/16/2022

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: 05/14/2023
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0027315775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 11/07/2021; 02/02/2022
• Supplement Dates FDA Received: 11/17/2021; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• 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