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

Model Number 3851

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was note that the balloon ruptured.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6) device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.Multiple hypotube kinks were noted in the hypotube shaft profile.The shaft polymer extrusion had no kinks or damages.Examination of the hypotube noted multiple kinks along the length of the hypotube.A detailed microscopic examination of the balloon material identified a pinhole leak, 12mm proximal to the distal tip.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.An attempt was then made to inflate the balloon to 12 atmospheres as per wolverine instruction for use using the inflation aid, however, a leak was noted coming from the pinhole tear at 12mm proximal to the distal tip.No other device issues were identified during returned product analysis.

Event Description

It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was note that the balloon ruptured.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19152182
• MDR Text Key: 340699513
• Report Number: 2124215-2024-24203
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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 Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0032750006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1