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 Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 09/23/2023

Event Type  malfunction  

Event Description

It was reported that the tip was fractured.The 96% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the tip was fractured and could not cross.The procedure was completed with a different device.No patient complications and the patient status was stable.

Manufacturer Narrative

E1 - (b)(6).

Event Description

It was reported that the tip was fractured.The 96% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the tip was fractured and could not cross.The procedure was completed with a different device.No patient complications and the patient status was stable.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Multiple kinks were noted along hypotube shaft.The shaft polymer extrusion had no kinks or damages.Multiple kinks were noted in various locations along the length of the hypotube shaft.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.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.

• 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: 19060391
• MDR Text Key: 339603130
• Report Number: 2124215-2024-20941
• 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
• Report Date: 04/08/2024

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: 0031179177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 87 KG