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 Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older a visual and microscopic examination was performed on the returned device.The device was returned in two separate sections, with the distal section still loaded onto an unknown 0.014 inch guidewire.A visual and tactile examination identified a complete break in the shaft polymer extrusion approximately 1460mm distal to the strain relief.Severe stretching and kinking damage was also noted on the shaft polymer extrusion.Due to this severe damage the customer's guidewire could not be removed from the wolverine device.This type of damage is consistent with excessive force being applied to the delivery system.A visual examination identified that the balloon material was severely bunched up.This type of damage is consistent with excessive force being applied to the delivery system.A visual and microscopic examination of the balloon material did not identify any tears in the material.The markerbands and blades 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.All blades were present and fully bonded to the balloon material.A visual and microscopic examination of the tip identified severe kinking and stretching damage.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination identified multiple kinks on the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.

Event Description

Reportable based on the product analysis completed on (b)(6) 2019.It was reported that insertion and withdrawal difficulty occurred.A percutaneous coronary intervention was being performed on a 75% stenosed, moderately calcified and moderately tortuous lesion in the mid right coronary artery.The 10mmx3.00mm wolverine coronary cutting balloon was used successfully once.After removal, the physician tried to advance it again, but there was severe resistance.When the balloon was advanced into the proximal y-connector, it was unable to cross and the balloon was difficult to remove.After applying force, the balloon was removed, however, the balloon was noted to be damaged/crushed.The procedure was successfully completed with a different device without issue or patient injury.However, the returned product analysis revealed that a shaft break occurred.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8412276
• MDR Text Key: 138528388
• Report Number: 2134265-2019-02061
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0022912241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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