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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 Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6 atmospheres.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6 atmospheres.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that balloon inflation failed because there was a hole on the shaft at the proximal side of this balloon catheter.The balloon was simply and completely removed from the patient's body.
 
Manufacturer Narrative
Corrections: h6 device codes: a0412: material rupture initially reported, corrected to a041001: material puncture/hole.Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon wings were found tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.A small protrusion was identified on the shaft polymer extrusion during a tactile examination at 13.8cm proximal to the tip.The device was attached to an encore inflation device and during an attempt to inflate the balloon of the device, a pinhole was noted at the protrusion site on the outer extrusion of the shaft polymer extrusion.No issues were noted with the inner extrusion at this site.Multiple hypotube kinks were also present on the device.The balloon of the device failed to maintain pressure due to the presence of a pinhole on the outer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 6 atmospheres.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that balloon inflation failed because there was a hole on the shaft at the proximal side of this balloon catheter.The balloon was simply and completely removed from the patient's body.
 
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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 Key11600060
MDR Text Key243346270
Report Number2134265-2021-04191
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,Followup
Report Date 05/26/2021
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 Date10/18/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026206469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Initial Date Manufacturer Received 03/22/2021
Initial Date FDA Received03/31/2021
Supplement Dates Manufacturer Received04/07/2021
05/05/2021
Supplement Dates FDA Received04/29/2021
05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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