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 Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that the tip was fractured.The 80% target lesion was located in the mildly tortuous and mildly calcified right coronary artery (rca).A 10mmx2.50mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci) for bifurcation lesion in distal rca.During the procedure, the packaging was opened according to the required steps and it was found that the tip of the device was fractured.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination identified no kinks or damages.The device was received in two sections as a result of a break which occurred in the distal extrusion.The break was located at the guidewire exit port.A microscopic examination of the break site identified that that there was clear evidence that excessive tensile force had been applied to the extrusion as the shaft exhibited clear signs of stretching at the break site.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A detailed microscopic examination of the balloon material identified no damages.The balloon was folded.A microscopic examination of the tip section found no damage.

Event Description

It was reported that the tip was fractured.The 80% target lesion was located in the mildly tortuous and mildly calcified right coronary artery (rca).A 10mmx2.50mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci) for bifurcation lesion in distal rca.During the procedure, the packaging was opened according to the required steps and it was found that the tip of the device was fractured.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• 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: 18671028
• MDR Text Key: 335555825
• Report Number: 2124215-2024-06864
• 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: 03/28/2024

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: 0032429624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG