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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK? PLUS; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC - CORK ROTALINK? PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number H749236310020
Device Problems Entrapment of Device (1212); Occlusion Within Device (1423); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
Same case as:2134265-2014-07849.It was reported that the burr was stuck on rotawire.A 99% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.25mm rotalink¿ plus and a 330cm rotawire¿ and wireclip¿ torquer were used for treatment.During platforming, rotational speed was checked using dynaglide mode and was noticed to be working properly as it went up to 200,000 rpm outside the body.However, abnormal sound was heard and the device stalled.The rotablator system was then removed from the body.It was then noted that the rotawire got stuck with the burr.Separating the rotawire from the burr was unsuccessful.The procedure was completed with a 1.5mm rota burr and 330cm rotawire.There were no complications reported and the patient's status was good.
 
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: the complaint unit was returned connected to the catheter.A visual examination of the complaint unit was carried out and no issues were noted.The advancer knob was locked upon return in a backward position; it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and no damage was noted.A handshake connection test was attempted to examine the integrity of the connection.No issues were noted.The drive shaft, coil and sheath were inspected and there was no damage noted.A guidewire was returned running through the device.The guidewire was removed with no resistance encountered.A wet test was performed and the device was unable to reach optimum speed of 176k rpm at 40 psi.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
Same case as:2134265-2014-07849.It was reported that the burr was stuck on rotawire.A 99% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 1.25mm rotalink¿ plus and a 330cm rotawire¿ and wireclip¿ torquer were used for treatment.During platforming, rotational speed was checked using dynaglide mode and was noticed to be working properly as it went up to 200,000 rpm outside the body.However, abnormal sound was heard and the device stalled.The rotablator system was then removed from the body.It was then noted that the rotawire got stuck with the burr.Separating the rotawire from the burr was unsuccessful.The procedure was completed with a 1.5mm rota burr and 330cm rotawire.There were no complications reported and the patient's status was good.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that after the devices were removed from the patient, the rotawire was observed to be separated.Another unspecified size rotawire was attempted to be inserted into the same burr; however, the burr was blocked.It was believed that the wire separated as the wire came in contact with the burr.
 
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Brand Name
ROTALINK? PLUS
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4342189
MDR Text Key21448170
Report Number2134265-2014-07848
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
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,Followup
Report Date 12/01/2014
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 Date08/31/2016
Device Model NumberH749236310020
Device Catalogue Number23631-002
Device Lot Number0017270168
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2015
Initial Date FDA Received12/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received02/09/2015
04/01/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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