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 Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A wolverine cb mr, ous 10mmx2.50mm was returned for analysis.A visual and tactile examination identified a complete break of the hypotube located approximately 220mm distal of the strain relief.The hypotube was also noted to be kinked at more than one location along its length.An examination of the returned device identified that the balloon had not been inflated.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A microscopic examination identified no damage to the tip of the device.The investigator was unable to apply vacuum due to the hypotube break, however a mandrel loaded, and the device was successfully loaded through a lab 6fr sheath without any resistance encountered.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 22mar2020.It was reported that a shaft bent occurred.The 75% and 100% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention (pci).During procedure, it was noted that the shaft got bent/kink.When using 6fr guiding catheter, there was severe resistance noted during insertion utilizing anchor balloon technique with a 1.5mm balloon catheter.Subsequently, there was no visual issue noted prior to the procedure the procedure was completed with another of same device.There were no patient complications reported and patient was good post procedure.However, device analysis revealed complete break of the hypotube located approximately 220mm distal of the strain relief.

• 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: 9972506
• MDR Text Key: 188248436
• Report Number: 2134265-2020-03803
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024505183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• 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