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 Leak/Splash (1354)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that a balloon leak occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the balloon was inflated up to 6 atm, it was noted that the balloon leaked.The procedure was completed successfully.No patient complications were reported.

Event Description

It was reported that a balloon leak occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the balloon was inflated up to 6 atm, it was noted that the balloon leaked.The procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A visual and tactile examination identified no kinks in the shaft polymer extrusion.A visual examination of the balloon identified no damage to the actual balloon material however, there was a large build-up of blood in the balloon.This blood is consistent with a leak having occurred in the device.A microscopic examination of the distal extrusion identified that the inner /wire lumen was kinked at approximately 1mm proximal to the proximal markerband.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.The tip showed no signs of damage.A microscopic examination of the proximal and distal markerbands identified no damage.After the leak was identified, the device was dissected so that the inner/wire lumen could be inspected.A microscopic examination of the lumen identified a kink, just proximal to the proximal markerband and a pinhole in the lumen at the site of the kink.This pinhole resulted in the leak out through the tip.During an attempt to insert a 0.014-inch wire through the wire lumen, resistance was encountered at the site of the kink, approximately 1mm proximal from the proximal markerband.The device was attached to a pretested encore inflation unit and it was noted that the balloon could inflate with no leaks noted in the balloon.However, a small leak was noted out through the tip of the device.This type of leak is consistent with a leak/breach between the inner/wire lumen and the inflation lumen.No other issues were identified during the 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: 16692502
• MDR Text Key: 312811588
• Report Number: 2124215-2023-15664
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028961581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Race: Asian