Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 39467-150
Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907); Output Problem (3005); Intermittent Loss of Power (4016)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/21/2022
Event Type  Injury  
Event Description
It was reported that the burr became stuck in the lesion, a burr and wire separation occurred.The 90% stenosed target lesion was located in a severely calcified and severely tortuous right coronary artery.A 1.50mm rotapro and a rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.During the seventh ablation, when the burr was returning from the distal part of the lesion, the device stalled and the burr became stuck in the lesion.The rotation was applied with dynaglide mode, however the drive shaft and the tip burr were detached.Angiography was performed, and the rotawire did not appear to be detached.The guide extension 7fr was advanced into the rotawire near the lesion.The lesion was unable to be crossed, and the rotawire was separated at 291 cm, as tension was applied for the device to cross the lesion.An attempt was made to recover the burr and rotawire by using a snare, but was unsuccessful.A surgical procedure was performed.After performing coronary artery bypass grafting (cabg) surgery, the patient's condition was stable.About 9 cm of the separated wire was recovered, but the burr that was stuck in the calcified lesion could not be recovered and was left inside the patient.There were no patient complications and the patient was in a stable condition post procedure.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that the burr became stuck in the lesion, a burr and wire separation occurred.The 90% stenosed target lesion was located in a severely calcified and severely tortuous right coronary artery.A 1.50mm rotapro and a rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.During the seventh ablation, when the burr was returning from the distal part of the lesion, the device stalled and the burr became stuck in the lesion.The rotation was applied with dynaglide mode, however the drive shaft and the tip burr were detached.Angiography was performed, and the rotawire did not appear to be detached.The guide extension 7fr was advanced into the rotawire near the lesion.The lesion was unable to be crossed, and the rotawire was separated at 291 cm, as tension was applied for the device to cross the lesion.An attempt was made to recover the burr and rotawire by using a snare, but was unsuccessful.A surgical procedure was performed.After performing coronary artery bypass grafting (cabg) surgery, the patient's condition was stable.About 9 cm of the separated wire was recovered, but the burr that was stuck in the calcified lesion could not be recovered and was left inside the patient.There were no patient complications and the patient was in a stable condition post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy device.The burr was not returned for analysis.In accordance with the reported events.The advancer, drive shaft, handshake connections, housing, sheath, and coil were visually and microscopically examined.Inspection of the device found that the burr catheter handshake connection was within the sheath and could not be retrieved.In order to inspect the handshake connection, the burr housing was dismantled and it was found that the coil was kinked, stretched, and broken next to the handshake connection within the sheath.Wear was identified within the sheath.The distal end of the coil was examined and it was found that the coil was stretched and broken at the point of detachment from the burr.In order to determine the functionality of the advancer, a test burr catheter was used as the returned burr catheter handshake connection was not able to be withdrawn from the sheath and could not be used for analysis.During functional testing, the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the advancer was able to reach and maintain optimal rpm using a test burr catheter.Inspection of the remainder of the device, revealed no damage or irregularities.A2: age at time of event: 18 years or older.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14988291
MDR Text Key295710797
Report Number2134265-2022-07804
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/22/2022
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 Date12/15/2023
Device Model Number39467-150
Device Catalogue Number39467-150
Device Lot Number0028564174
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2022
Initial Date FDA Received07/12/2022
Supplement Dates Manufacturer Received08/02/2022
Supplement Dates FDA Received08/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
-
-