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

Model Number 3852

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that the balloon leaked.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 15mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, it was noted that there was blood in the manifold.It was felt that the wolverine cutting balloon could be damaged and was leaking due to the calcified lesion.The procedure was completed with a non-boston scientific device.No complications were reported.

Manufacturer Narrative

E1: initial reporter first name and initial reporter last name: corrected.Device evaluated by mfr: the device was returned for analysis.Visual examination of the balloon identified blood in the balloon material.No issues were noted with the hypotube shaft.No kinks or damages were noted with the polymer shaft.Traces of blood were identified in the manifold.Microscopic examination of the balloon identified a build-up of solidified blood in the balloon.When inflating the balloon a pinhole was located above the proximal markerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No kinks or damages were noted with the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.When inflating the balloon to its rated burst pressure of 12 atmospheres a pinhole was located above the proximal markerband.

Event Description

It was reported that the balloon leaked.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 15mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, it was noted that there was blood in the manifold.It was felt that the wolverine cutting balloon could be damaged and was leaking due to the calcified lesion.The procedure was completed with a non-boston scientific device.No complications were 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18695982
• MDR Text Key: 335257632
• Report Number: 2124215-2024-07549
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0031709643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2023
• 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