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 Puncture/Hole (1504); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2019

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified mid right coronary artery.A 10mmx2.00mm and a 10mmx2.25mm wolverine coronary cutting balloon were selected for use.During procedure, the 2.25mm balloon was first advanced.Soon after the inflation was started, the balloon ruptured at 2-3atm.It was noted that contrast media leaked out immediately after the pressure was increased.It was noted it seemed that there was already a hole in the balloon when it was advanced to the lesion.Afterwards, the 2.00mm balloon was advanced and dilation was performed; however, the balloon ruptured at 4atm for 6 seconds.It was suspected that the device ruptured due to the prominent calcified lesion.The devices were simply removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient was good post-procedure.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9162110
• MDR Text Key: 161857206
• Report Number: 2134265-2019-12056
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950020
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023663451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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