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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 2077-01
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/27/2023
Event Type  Injury  
Event Description
It was reported that catheter tip separation occurred and remained inside the patient's body.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A rotawire drive was selected for use.Upon opening the package, it was noted that the wire tip seemed to be slightly bent.During the procedure, the opaque tip, approximately 1.2cm from the tip, was separated.There was resistance encountered when removing the device from the patient's body.The detached portion was not recovered as the wire separated at the periphery.It was noted the distal end had already been slightly bent when the device was unpacked.The procedure was completed with this device.No further patient complications reported.
 
Manufacturer Narrative
E1- initial reporter facility name: (b)(6) hospital.
 
Manufacturer Narrative
E1- initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: the device was returned for analysis.The wire body, proximal end, and spring tip were visually and microscopically examined.Inspection of the device found that the rotawire was kinked at 139.5cm from the proximal end and that the distal end of the spring tip was detached.Product analysis confirmed the reported separation, as the distal end of the spring tip was separated.The reported difficulty during removal was not able to be confirmed as clinical circumstances were not able to be replicated.The reported bent tip was not able to be confirmed due to the tip separation.
 
Event Description
It was reported that catheter tip separation occurred and remained inside the patient's body.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A rotawire drive was selected for use.Upon opening the package, it was noted that the wire tip seemed to be slightly bent.During the procedure, the opaque tip, approximately 1.2cm from the tip, was separated.There was resistance encountered when removing the device from the patient's body.The detached portion was not recovered as the wire separated at the periphery.It was noted the distal end had already been slightly bent when the device was unpacked.The procedure was completed with this device.No further patient complications reported.
 
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Brand Name
ROTAWIRE DRIVE
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18537323
MDR Text Key333162753
Report Number2124215-2023-76040
Device Sequence Number1
Product Code MCX
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2024
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 Model Number2077-01
Device Catalogue Number2077-01
Device Lot Number0031931272
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2023
Initial Date FDA Received01/18/2024
Supplement Dates Manufacturer Received03/18/2024
Supplement Dates FDA Received04/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2023
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) Other;
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