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 Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.A visual examination of the balloon identified no damages.No issues were noted on the hypotube shaft.Visual examination could not identify any kinks or damages in the shaft polymer extrusion.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 polymer extrusion appeared to have no issues however, when inflated to rated burst pressure (rbp), pinhole leaks were noted along the polymer extrusion shaft 4cm, 4.9cm and 10cm form the tip of the device.The distal extrusion was dissected, and a microscopic examination of the inner lumen identified no tear or damage.The tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 21sep2023.It was reported that a balloon leak was noted.The 30mm x 3.0-3.5mm, 95% stenosed target lesion was located in the non- tortuous and mildly calcified middle section of left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was dilated at a pressure of 4atm in the patient's body, and it was found that the balloon could not dilate.The balloon was removed and a balloon leak was found in vitro test.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.However, device analysis revealed pinhole leaks along the polymer extrusion shaft.

• 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: 17872572
• MDR Text Key: 324942758
• Report Number: 2124215-2023-53896
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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: 0030093678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 66 KG