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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3241
Device Problem Mechanical Problem (1384)
Patient Problems Perforation of Vessels (2135); Discomfort (2330)
Event Date 06/25/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).Age at time of event: 18 years or older.
 
Event Description
It was reported that perforation occurred.The target lesion was located in the severely calcified mid to proximal right coronary artery (rca).A 1.50mm rotalink plus was selected for use.During procedure, after performing first ablation at proximal rca and second ablation at mid rca at a burr speed of 150,000-155,000rpm, the console was noted to have a wheezing sound before stalling upon third ablation.The burr stalled in the proximal rca and was removed backwards into the 6fr guiding catheter.However, a perforation was noted in the proximal rca.A balloon was then used to limit the bleeding and followed by stenting with a covered stent.The procedure was not completed due to the event.The patient was transferred to high dependency ward in a stable condition.
 
Manufacturer Narrative
Patient identifier- (b)(6).Age at time of event: 18 years or older.Device was evaluated by the manufacturer.The device was returned for analysis.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically examined.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil is stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to a melted ultem.The most likely cause of the melted ultem was due to insufficient flow of saline during use.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that perforation occurred.The target lesion was located in the severely calcified mid to proximal right coronary artery (rca).A 1.50mm rotalink plus was selected for use.During procedure, after performing first ablation at proximal rca and second ablation at mid rca at a burr speed of 150,000-155,000rpm, the console was noted to have a wheezing sound before stalling upon third ablation.The burr stalled in the proximal rca and was removed backwards into the 6fr guiding catheter.However, a perforation was noted in the proximal rca.A balloon was then used to limit the bleeding and followed by stenting with a covered stent.The procedure was not completed due to the event.The patient was transferred to high dependency ward in a stable condition.It was further reported that the patient experienced some chest discomfort.It was unknown when the perforation occurred.It was noted that the patient felt discomfort when the burr had stalled.The patient was stable and discharged.
 
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Brand Name
ROTALINK PLUS
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8744044
MDR Text Key149498770
Report Number2134265-2019-07533
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729228363
UDI-Public08714729228363
Combination Product (y/n)N
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/23/2019
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 Date02/24/2021
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0023547313
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Initial Date Manufacturer Received 06/25/2019
Initial Date FDA Received06/28/2019
Supplement Dates Manufacturer Received07/02/2019
Supplement Dates FDA Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER- 6FR 3.5; GUIDE CATHETER- 6FR 3.5; GUIDEWIRE- ASAHI SION BLUE; GUIDEWIRE- ASAHI SION BLUE; GUIDEWIRE- RUNTHROUGH; GUIDEWIRE- RUNTHROUGH; GUIDE CATHETER- 6FR 3.5; GUIDEWIRE- ASAHI SION BLUE; GUIDEWIRE- RUNTHROUGH
Patient Outcome(s) Required Intervention;
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