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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3600
Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2019
Event Type  malfunction  
Event Description
It was reported that the wire coating peeled off.A 330cm rotawire and 1.75mm rotalink plus were selected for use.During preparation, it was noted that the wire coating was peeled off when inserted into the burr outside patient's body.Subsequently, a large amount of coating material adhered on the tip of the rotaburr.The rotawire was replaced but the rotawires felt rough and the coating was uneven.Ablation was then stopped and the procedure was completed with the usual percutaneous coronary intervention (pci).No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by the manufacturer: the device wasreturned for analysis.The surface of the device was carefully inspected and some residues were found on some sections of it.Previous to performing the decontamination process, the device was inspected looking for the coating the issues reported by the customer.The surface looked in good condition, however, white residues were encountered on its surface and they looked like lumps.The surface of the device was inspected again and some residues were observed on the surface; however, the guidewire surface did not show abnormalities, it was in good condition.Besides, the device had the distal tip stretched.No more damages were found in the device.The dimensional inspection revealed that the overall length and the outer diameter (od) of the distal tip, middle of the device, and the proximal section were within specification.The directions for use indicate the following:"exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation." "the guidewires are coated with a thin film of lubricant which may appear as a white powder.Do not wipe off lubricious coating.The lubricant can cause the guidewire to adhere to the inside of the tube, making unloading difficult.If this happens, gently tap the outside of the coil to loosen the wire.Use care not to stretch or damage the spring tip.".
 
Event Description
It was reported that the wire coating peeled off.A 330cm rotawire and 1.75mm rotalink plus were selected for use.During preparation, it was noted that the wire coating was peeled off when inserted into the burr outside patient's body.Subsequently, a large amount of coating material adhered on the tip of the rotaburr.The rotawire was replaced but the rotawires felt rough and the coating was uneven.Ablation was then stopped and the procedure was completed with the usual percutaneous coronary intervention (pci).No patient complications were reported.
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8851267
MDR Text Key152953908
Report Number2134265-2019-09109
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729195573
UDI-Public08714729195573
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 09/03/2019
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 Date08/12/2020
Device Model Number3600
Device Catalogue Number3600
Device Lot Number0022508463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2019
Initial Date Manufacturer Received 07/11/2019
Initial Date FDA Received08/01/2019
Supplement Dates Manufacturer Received08/12/2019
Supplement Dates FDA Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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