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 Material Rupture (1546); Failure to Advance (2524)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).

Event Description

It was reported that the balloon ruptured.The 75% stenosed target lesion was located in a moderately tortuous and severely calcified posterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the lesion was becoming difficult to cross and was severely difficult to insert the device.Afterwards, inflation was continuously performed several times at 10atm twice for 10 seconds each and at 12atm for three times at 10 seconds each before reaching the lesion.However, the balloon ruptured at 12atm.The balloon was deflated for 20 to 30 seconds, there was a slight resistance felt upon withdrawing the balloon and was then simply pulled out from the patient's body.The procedure was completed with a different device.There were 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12268625
• MDR Text Key: 264791224
• Report Number: 2134265-2021-09880
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027070517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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
• Treatment: BALLOON CATHETER-RYUREI 2.0X15; GUIDE CATHETER-6F HYPERION AL1; GUIDEWIRE-RUNTHROUGH; IMAGING CATHETER-ALTAVIEW; INFLATION DEVICE-MEDTRONIC EVEREST; INTRODUCER SHEATH-6F RADIFOCUS