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

Model Number 3850

Device Problems Break (1069); Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter city: (b)(6).

Event Description

It was reported that the catheter proximal part was separated.A 6mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, after the setup of this device, there appeared to be strong resistance during insertion into the guiding catheter.The proximal shaft of this device was kinked, and when the entire catheter was pulled out, the outer part of the catheter appeared to be separated.The procedure was completed with another of the same device.No patient complications reported.

Event Description

It was reported that the catheter proximal part was separated.A 6mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, after the setup of this device, there appeared to be strong resistance during insertion into the guiding catheter.The proximal shaft of this device was kinked, and when the entire catheter was pulled out, the outer part of the catheter appeared to be separated.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

E1 - initial reporter city: kakegawa city, shizuoka prefecture.Device evaluated by mfr.: the device was returned for analysis.Multiple kinks were identified along the hypotube shaft.A break was also identified, 21cm distal to the distal end of the strain relief.The shaft polymer extrusion had no kinks or damages.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.Multiple kinks were identified along the hypotube shaft.A break was also identified, 21cm distal to the distal end of the strain relief.A microscopic examination of the proximal and distal markerbands identified no damage.The device could be loaded and tracked along a 0.014-inch guidewire.A break was identified in the hypotube, 21cm distal to the distal end of the strain relief.However, a 6f introducer sheath would be loaded onto the device with no issues.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: 19025810
• MDR Text Key: 339208895
• Report Number: 2124215-2024-19953
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/25/2024

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: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0031595747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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