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

Model Number 3851

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon ruptured upon second inflation at 8 atm for 5 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

Event Description

It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon ruptured upon second inflation at 8 atm for 5 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Multiple kinks were identified along the hypotube shaft.Multiple kinks were identified along the shaft polymer extrusion.Microspoic examination of the balloon identified a tear 2mm distal from the mid-section of the blades/balloon.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.Multiple kinks were identified along the hypotube shaft.Multiple kinks were identified along the shaft polymer extrusion.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19101635
• MDR Text Key: 340457275
• Report Number: 2124215-2024-22460
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• 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: 0032676051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG