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

Model Number 3851

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that the shaft had a pinhole damage.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, a shaft pinhole damage was noted in the device.The device was removed by usual method without any problem and the procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

E1 - (b)(6).

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6) e1 - initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and tactile inspection revealed no issues identified with the hypotube shaft.The shaft polymer extrusion had no kinks or damages visible, and no tears were visible in the balloon material.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.There was a large build-up of blood inside the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.After a pinhole leak was identified in the outer extrusion, a microscopic examination of the leak site identified a pinhole in the outer lumen.Damage was also observed in the inner/wire lumen at the site of the pinhole in the outer (13.6cm proximal from the tip of the device).Using a blade, the distal extrusion was dissected so that the inner/wire lumen could be examined more closely.It was confirmed that a pinhole also existed in the inner/wire lumen at 13.6cm proximal from the tip of the device.The tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.Functional testing was performed using an encore inflation unit; an attempt was made to inflate the balloon when a pinhole leak was confirmed in the distal extrusion.The pinhole leak was located at 13.6cm proximal from the tip of the device.No other damages were observed with the actual device.There was a large build-up of blood present inside the balloon.This blood likely entered the balloon due to the pinhole in the distal extrusion.

Event Description

It was reported that the shaft had a pinhole damage.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, a shaft pinhole damage was noted in the device.The device was removed by usual method without any problem and the procedure was completed with another of the same device.No patient complications reported.

• 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: 18887572
• MDR Text Key: 337460616
• Report Number: 2124215-2024-14516
• 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: 04/17/2024

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: 0032971035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2023
• 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