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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 Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/25/2022
Event Type  Injury  
Event Description
It was reported that a balloon rupture occurred and half of the blade went missing.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.A 10mmx3.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured at 12 atmospheres for 10 seconds upon third inflation.The device was then able to be pulled out with the usual method with a little resistance.However, half of the blade was noted to be missing and the possibility of it remaining inside the body cannot be denied.Furthermore, the blade was lifted.The procedure was completed with a different device.No complications reported and the patient is in good condition after the procedure.
 
Manufacturer Narrative
Initial reporter city(b)(6).
 
Event Description
It was reported that a balloon rupture occurred and half of the blade went missing.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid right coronary artery.A 10mmx3.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured at 12 atmospheres for 10 seconds upon third inflation.The device was then able to be pulled out with the usual method with a little resistance.However, half of the blade was noted to be missing and the possibility of it remaining inside the body cannot be denied.Furthermore, the blade was lifted.The procedure was completed with a different device.No complications reported and the patient is in good condition after the procedure.
 
Manufacturer Narrative
E1.Initial reporter city- (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was in a deflated state.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located the balloon mid-section.An examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complaint.Four blades were present on the balloon surface however, the following blade damage was noted on two blades: blade 1: blade lift was noted on the proximal blade segment and no issues were noted with the pad of this blade.It was fully adhered to the balloon surface.Blade 2: the proximal blade segment was found to be missing from its pad.The blade pad was found to be fully adhered to the balloon surface.No issues were noted with blade 3 or 4.A visual and tactile examination identified no issues noted on the hypotube.A visual and tactile examination identified no issues on the shaft polymer extrusion.The marker bands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15438429
MDR Text Key300050131
Report Number2124215-2022-34279
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0029577069
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2022
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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