MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	3853
Medical Device Problem Codes	Material Integrity Problem (2978); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: 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 Key: 17054698
• Report Number: 2124215-2023-26057
• Device Sequence Number: 19696687
• Product Code: NWX
• UDI-Device Identifier: 08714729888192
• UDI-Public: 08714729888192
• Combination Product (Y/N): N
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2024
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0029417510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown