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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3853
Device Problems Material Integrity Problem (2978); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2023
Event Type  malfunction  
Event Description
It was reported that the balloon could not be deflated.A 6mmx3.50mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that the balloon was inflated in the proximal part.When negative pressure was put, the balloon could not be deflated.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that the balloon could not be deflated.A 6mmx3.50mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that the balloon was inflated in the proximal part.When negative pressure was put, the balloon could not be deflated.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination of hypotube shaft identified no damages.A visual examination of the distal extrusion identified no damages.A visual examination of the balloon identified that the proximal folds in the balloon were relaxed (not tightly folded).Microscopic examination of the inner/wire lumen identified no damages.A detailed microscopic examination of the balloon material identified no damages.A microscopic examination of the balloon identified that the proximal folds in the balloon were relaxed (not tightly folded).All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no issues.The device was attached to a pre-tested encore inflation device (tested using the druck pressure gauge) and the balloon was inflated to its rated burst pressure (rbp) of 12 atmospheres (per instructions for use) with no leaks noted.A vacuum was applied, and the balloon deflated fully.Although the balloon deflated fully the balloon did not rewrap/refold.This is not a defect with the balloon.No other issues were identified during the product analysis.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17054698
MDR Text Key316497214
Report Number2124215-2023-26057
Device Sequence Number1
Product Code NWX
UDI-Device Identifier08714729888192
UDI-Public08714729888192
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3853
Device Catalogue Number3853
Device Lot Number0029417510
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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