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 Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6)years or older.Initial reporter city: (b)(4).

Event Description

It was reported that the balloon ruptured.The 75% stenosed target lesion area was located in a moderately tortuous and severely calcified mid left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, difficulty crossing the lesion was encountered.Dilation was performed at 6 atmospheres once, 10 atmospheres twice and 12 atmospheres twice.However, the balloon ruptured.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: 11012073
• MDR Text Key: 221542113
• Report Number: 2134265-2020-17737
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026094969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER -8F HYPERION; GUIDEWIRE-SION BLUE; IMAGING CATHETER- ALTAVIEW; INFLATION DEVICE-ENCORE26; INTRODUCER SHEATH -8F RADIFOCUS