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 Break (1069); Failure to Advance (2524); Material Integrity Problem (2978)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

It was reported that the balloon tip was broken.The target lesion was located in the moderately calcified middle and distal left anterior descending artery.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.Upon unpacking, the balloon tip was noted to be slightly kinked and damage, but the device was still used for the procedure.Upon advancing, the device passage was not smooth and impaired crossing in and around the lesion was experienced.The device was removed using the normal method and a 3-4 cm breakage was noted.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Event Description

It was reported that the balloon tip was broken.The target lesion was located in the moderately calcified middle and distal left anterior descending artery.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.Upon unpacking, the balloon tip was noted to be slightly kinked and damage, but the device was still used for the procedure.Upon advancing, the device passage was not smooth and impaired crossing in and around the lesion was experienced.The device was removed using the normal method and a 3-4 cm breakage was noted.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received coiled up.A visual examination identified multiple kinks along the coiled hypotube.During an attempt to uncoil the device, a break occurred in the hypotube.The break was located approximately 12 cm distal from the strain relief.A visual examination of the distal extrusion identified no damages.A visual examination of the balloon identified that the proximal folds in the balloon were relaxed (not tightly folded).Microscopic examination of the inner/wire lumen identified no damages.A detailed microscopic examination of the balloon material identified no damages.A microscopic examination of the balloon identified that the proximal folds in the balloon were relaxed (not tightly folded).All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no issues.

• 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: 17282942
• MDR Text Key: 318765393
• Report Number: 2124215-2023-35174
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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: 0030440028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG