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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 Entrapment of Device (1212)
Patient Problems Death (1802); No Code Available (3191)
Event Date 08/29/2020
Event Type  Death  
Event Description
It was reported that the burr became stuck in the lesion.Vascular access was obtained via femoral approach.The 80% stenosed, 25x2.5mm concentric, de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.The lesion was predilated resulting in 70% residual stenosis.The lesion was engaged using a 7fr guide catheter.A 1.25mm rotalink plus was selected for use.A rotawire crossed through the lesion and the rotalink plus burr was loaded onto the wire.The rotalink plus burr was advanced and parked proximal to the lesion and the rpms were set to 180k.Rotablation was started and after one run for 15 seconds at 175k rpm, the rotalink plus burr became entrapped in the lesion.An attempt to remove the burr in dynaglide mode was made; however, was not successful.The burr was manually pulled but did not move from the lesion and it was noted that the drive shaft was elongating.The physician cut the drive shaft and attempted to remove the burr using a guidezilla but was unable to withdraw the burr.The procedure was abandoned and the patient went to surgery.
 
Event Description
It was reported that the burr became stuck in the lesion.Vascular access was obtained via femoral approach.The 80% stenosed, 25x2.5mm concentric, de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.The lesion was predilated resulting in 70% residual stenosis.The lesion was engaged using a 7fr guide catheter.A 1.25mm rotalink plus was selected for use.A rotawire crossed through the lesion and the rotalink plus burr was loaded onto the wire.The rotalink plus burr was advanced and parked proximal to the lesion and the rpms were set to 180k.Rotablation was started and after one run for 15 seconds at 175k rpm, the rotalink plus burr became entrapped in the lesion.An attempt to remove the burr in dynaglide mode was made; however, was not successful.The burr was manually pulled but did not move from the lesion and it was noted that the drive shaft was elongating.The physician cut the drive shaft and attempted to remove the burr using a guidezilla but was unable to withdraw the burr.The procedure was abandoned and the patient went to surgery.It was further reported that a coronary artery bypass graft was performed and the burr was removed.Four days after the procedure, the patient died.
 
Manufacturer Narrative
Device evaluated by mfr: the returned complaint device consisted of a rotablator plus device.The burr catheter was attached to the advancer when received.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed that the coil is stretched and separated 13.1cm from the handshake connection.The sheath is separated 6.5cm from the nosecone.The distal section of the coil, sheath, and the burr is missing.Microscopic examination revealed no damages.Functional testing was performed by rotating the drive shaft and it was unable to rotate.The drive shaft lack of rotation is an indication of a melted ultem.Inspection of the remainder of the device presented no damage or irregularities.A melted ultem would cause the device to stall and become potentially become stuck in the lesion.
 
Manufacturer Narrative
Correction - a4 unit of measure weight: lb to kg.
 
Event Description
It was reported that the burr became stuck in the lesion.Vascular access was obtained via femoral approach.The 80% stenosed, 25x2.5mm concentric, de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.The lesion was predilated resulting in 70% residual stenosis.The lesion was engaged using a 7fr guide catheter.A 1.25mm rotalink plus was selected for use.A rotawire crossed through the lesion and the rotalink plus burr was loaded onto the wire.The rotalink plus burr was advanced and parked proximal to the lesion and the rpms were set to 180k.Rotablation was started and after one run for 15 seconds at 175k rpm, the rotalink plus burr became entrapped in the lesion.An attempt to remove the burr in dynaglide mode was made; however, was not successful.The burr was manually pulled but did not move from the lesion and it was noted that the drive shaft was elongating.The physician cut the drive shaft and attempted to remove the burr using a guidezilla but was unable to withdraw the burr.The procedure was abandoned and the patient went to surgery.It was further reported that a coronary artery bypass graft was performed and the burr was removed.Four days after the procedure, the patient died.
 
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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 Key10488413
MDR Text Key205502967
Report Number2134265-2020-12217
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729316411
UDI-Public08714729316411
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,Followup
Report Date 11/06/2020
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 Date08/30/2021
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0024516231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Initial Date Manufacturer Received 08/29/2020
Initial Date FDA Received09/03/2020
Supplement Dates Manufacturer Received09/07/2020
10/29/2020
Supplement Dates FDA Received09/22/2020
11/06/2020
Patient Sequence Number1
Treatment
GUIDE CATHETER: 7F EBU 3.5; GUIDE CATHETER: 7F EBU 3.5; GUIDE CATHETER: 7F EBU 3.5; GUIDE CATHETER: 7F EBU 3.5
Patient Outcome(s) Death; Required Intervention;
Patient Age78 YR
Patient Weight76
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