MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be inflated due to a shaft leak.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft leak located approximately 40mm proximal to the proximal balloon bond.A microscopic examination found the shaft to have a cut/abrasion on it.This type of damage is consistent with the device coming in to contact with a sharp object.A visual and tactile examination identified that the hypotube was kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon hole occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.During the procedure, it was noted that a 10mmx3.00mm wolverine coronary cutting balloon had a hole on the balloon on the distal shaft part.A 2.75 x 10 wolverine coronary cutting balloon had the same issue.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9396220
• MDR Text Key: 174402811
• Report Number: 2134265-2019-14235
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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