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 01/13/2024

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).

Event Description

It was reported that blade detachment occurred.The 10 mm x 4.00 mm wolverine cb was selected for use.When the device was removed from its packaging, it was noted that the blade was already detached from the balloon.The procedure was completed using an alternate device.There were no patient complications.

Manufacturer Narrative

E1 initial reporter address (b)(6).The device was returned for analysis.A visual/tactile and microscopic examination identified multiple kinks along the hypotube and no damage to the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified inflation media inside the balloon and the balloon exhibited clear signs of having been inflated.No tears or holes were evident in the balloon material.A microscopic examination of the blade segments revealed that of the four blade segments, one blade had approximately 2mm of the proximal end of a distal blade segment lifted.Another blade segment had approximately 1mm of the distal end of a proximal blade segment lifted.No other damage was noted to the other blades.Although two blade segments were lifted, no blade segments had detached from the balloon and all blade pads were fully bonded to the balloon.No issues were identified during examination of the shaft polymer extrusion profile.A microscopic examination of the tip section found that the distal edge of the tip was flared.No other issues were identified during the product analysis.

Event Description

It was reported that blade detachment occurred.The 10 mm x 4.00 mm wolverine cb was selected for use.When the device was removed from its packaging, it was noted that the blade was already detached from the balloon.The procedure was completed using an alternate device.There were no patient complications.

• 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: 18615063
• MDR Text Key: 334216933
• Report Number: 2124215-2024-05270
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 0031766431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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: 51 YR
• Patient Sex: Male
• Patient Race: Asian