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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3320
Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problems Death (1802); Respiratory Distress (2045); Injury (2348)
Event Date 11/16/2020
Event Type  Death  
Manufacturer Narrative
Weight: (b)(6).
 
Event Description
It was reported that the device was leaking liquid, the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.
 
Event Description
It was reported that the device was leaking liquid, the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.No further patient complications were reported.It was further reported that when the device was removed, it was found that the sheath of the 1.25mm rotalink burr was leaking.There was no device issue with the rotalink advancer.The patient was treated with a defibrillator and cannula.The patient was transferred to the cardiac care unit, and after a few days the patient died due to pulmonary atelectasis.It was further reported that the device passed pre-procedure testing and a catheter fracture may have occurred during the procedure.During pull back, the liquid was not flowing from the head of the burr and there was no cooling and lubrication effect.This may have caused the patient to have a severe reaction during the rotablation procedure.The leaking site was located in the very proximal of the burr catheter and it seems this part was always within the guiding catheter lumen and would not touch the patient's vessel during the procedure, so the fracture may not have been caused by the patient lesion.
 
Manufacturer Narrative
Weight: 75.9 kg.Date of death was approximated.
 
Manufacturer Narrative
A4: weight: 75.9 kg.B2: date of death was approximated.
 
Event Description
It was reported that the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.It was further reported that when the device was removed, it was found that the sheath of the 1.25mm rotalink burr was leaking.There was no device issue with the rotalink advancer.The patient was treated with a defibrillator and cannula.The patient was transferred to the cardiac care unit, and after a few days the patient died due to pulmonary atelectasis.
 
Manufacturer Narrative
A4 - weight: 75.9 kg.B2: date of death was approximated.Device evaluated by mfr: the device was returned for evaluation.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.The sheath is partially torn 20.5cm from the strain relief.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 has become stretched due to manipulation during the procedure.The advancer that was used with this device during the procedure was returned for analysis and was confirmed to stall.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
 
Event Description
It was reported that the device was leaking liquid, the patient had a very severe reaction and the procedure was cancelled.The target areas were in 70% stenosed ostial, 80-90% stenosed proximal to middle, and 80% stenosed distal end of the left circumflex artery.A rotalink advancer and a 1.25mm rotalink burr were selected for use.During procedure, the patient had a very severe reaction and rescue was carried out.It was found after the procedure that the middle part of the rotablator catheter was leaking liquid.The procedure was cancelled.No further patient complications were reported.It was further reported that when the device was removed, it was found that the sheath of the 1.25mm rotalink burr was leaking.There was no device issue with the rotalink advancer.The patient was treated with a defibrillator and cannula.The patient was transferred to the cardiac care unit, and after a few days the patient died due to pulmonary atelectasis.It was further reported that the device passed pre-procedure testing and a catheter fracture may have occurred during the procedure.During pull back, the liquid was not flowing from the head of the burr and there was no cooling and lubrication effect.This may have caused the patient to have a severe reaction during the rotablation procedure.The leaking site was located in the very proximal of the burr catheter and it seems this part was always within the guiding catheter lumen and would not touch the patient's vessel during the procedure, so the fracture may not have been caused by the patient lesion.
 
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Brand Name
ROTALINK BURR
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10898734
MDR Text Key218194764
Report Number2134265-2020-16191
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729185864
UDI-Public08714729185864
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,Followup
Report Date 01/05/2021
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 Date12/17/2021
Device Model Number3320
Device Catalogue Number3320
Device Lot Number0025060665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received11/25/2020
12/02/2020
12/21/2020
Supplement Dates FDA Received12/01/2020
12/04/2020
01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Other; Required Intervention;
Patient Age59 YR
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