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 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: 18 years or older.

Event Description

It was reported that a balloon rupture occurred.The patient presented with chest pain.Vascular access was obtained via the right radial artery.The 70% stenosed, 15mm, concentric, de nove (progression), target lesion was located in the moderately tortuous and moderately calcified vessel.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured at 4-6atm.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

A1 patient identifier: (b)(6).A2 age at time of event: 18 years or older.

Event Description

It was reported that a balloon rupture occurred.The patient presented with chest pain.Vascular access was obtained via the right radial artery.The 70% stenosed, 15mm, concentric, de novo (progression), target lesion was located in the moderately tortuous and moderately calcified vessel.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured at 4-6atm.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the balloon ruptured at second inflation within 10 seconds.The device was removed in one piece from the sheath.

• 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: 12830723
• MDR Text Key: 280940478
• Report Number: 2134265-2021-14478
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0027567449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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