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 Difficult to Insert (1316); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified middle left anterior descending artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, a 2.5x15 non-bsc ptca dilatation catheter was used for pre-dilatation but the catheter did not expand due to the calcification.Then, a 10x4 wolverine was used, however, it had difficulty crossing and inserting into the lesion area due to the calcification.After crossing the lesion, the balloon ruptured when dilatation was performed at 12 atm.All the components were completely removed from the patient's body.The procedure ended was completed with the orginal device as desired treatment was achieved.No complications reported and the patient was stable 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10460276
• MDR Text Key: 204564302
• Report Number: 2134265-2020-11731
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025567111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2020
• 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 2.5X15; GUIDE CATHETER: 8F HYPERION SPB3.5SH; GUIDEWIRE: SION BLUE; IMAGING CATHETER: ALTAVIEW; INFLATION DEVICE: ENCORE26; INTRODUCER SHEATH: 8F RADIFOCUS