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

Model Number 3852

Device Problem Material Rupture (1546)

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured when the device was advanced inside the patient or there was a reverse blood flow when a negative pressure was applied before the inflation.The procedure was completed with a different device.No patient complications reported.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Ial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual/tactile inspection revealed that the hypotube shaft profile had no issues identified.No issues were identified in the shaft polymer extrusion.Microscopic examination of the balloon identified a pinhole 2mm proximal from the proximal makerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to an encore inflation unit.A pinhole was located in the proximal section of the balloon when inflating to rated burst pressure of 12 atmospheres.The encore device was verified before and after use using the druck gauge.No other device issues were identified during returned product analysis.

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured when the device was advanced inside the patient or there was a reverse blood flow when a negative pressure was applied before the inflation.The procedure was completed with a different 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: 19163720
• MDR Text Key: 340825895
• Report Number: 2124215-2024-24480
• 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
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0032421239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• 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