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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the catheter was separated.The 90% stenosed target lesion was an area of instent restenosis (isr) located in the moderately tortuous and mildly calcified mid right coronary artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was not able to cross.When the device was removed from the patient's body, it was further noted that the middle part of the catheter became separated.The device was simply removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.
 
Event Description
It was reported that the catheter was separated.The 90% stenosed target lesion was an area of instent restenosis (isr) located in the moderately tortuous and mildly calcified mid right coronary artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was not able to cross.When the device was removed from the patient's body, it was further noted that the middle part of the catheter became separated.The device was simply removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.The device was received in two sections as the result of a break in the hypotube a visual and tactile examination identified a complete break of the hypotube located approximately 670mm distal of the strain relief.The hypotube was also noted to be kinked at more than one location along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted with the hypotube that may have contributed to the complaint incident.An examination of the returned device identified that the balloon had not been inflated.No issues were identified with the balloon which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A microscopic examination identified no damage to the tip of the device.No other issues were identified during the product analysis.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9430756
MDR Text Key169702085
Report Number2134265-2019-15116
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024490092
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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