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

Model Number	3854
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified nodular morpology distal right coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated thrice within 5-10 seconds after second inflation.However, at third inflation, it was noted that the balloon ruptured at 6atm.The device was removed from the patient easily through the guide catheter over the wire.The procedure was completed with the different device.No complications were reported, and patient was stable post procedure.
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified nodular morphology distal right coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated thrice within 5-10 seconds after second inflation.However, at third inflation, it was noted that the balloon ruptured at 6atm.The device was removed from the patient easily through the guide catheter over the wire.The procedure was completed with the different device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual, tactile and microscopic examination of the hypotube identified multiple kinking along the length of the hypotube.A visual, tactile and microscopic examination of the distal extrusion identified no kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.Using an encore inflation unit an attempt was made to inflate the balloon when a pinhole leak was confirmed.The pinhole was located over the proximal edge of the distal markerband.A leakage test performed on the device, confirmed that a pinhole leak did exist in the balloon material.No issues were noted with the actual device which could potentially have contributed to the pinhole leak.

• 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: 16990240
• Report Number: 2124215-2023-25583
• Device Sequence Number: 7168034
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 01/22/2025
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0030907199
• 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: 07/05/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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