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 Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluate by mfr: the device was returned for analysis.A visual and tactile examination identified multiple kinking along the length of the hypotube.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.A microscopic examination of the distal markerband found no issues which could potentially have contributed to the pinhole leak.The device was attached to an encore inflation device (tested using the druck pressure gauge at 12 atmospheres), and when an attempt was made to inflate the balloon, a leak was identified over the distal markerband.A microscopic examination of the balloon, at the site of the leak, confirmed that a pinhole existed in the balloon material.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the balloon could not be inflated and was leaking liquid.The 18mm, 2.5mm target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be inflated and it was leaking liquid.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, device analysis revealed that a pinhole existed in the balloon material.

• 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: 17999683
• MDR Text Key: 326491467
• Report Number: 2124215-2023-59164
• 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
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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: 0030056654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 71 KG