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

Model Number 3854

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.The complaint was reported to bsc on 19-oct-2018.A date of(b)(6) 2018 was entered into the date of event field to indicate an unknown date in (b)(6) 2018.

Event Description

It was reported that a component detachment occurred.While using a 10mm x 4.00mm wolverine coronary cutting balloon, the balloon and distal part of the catheter detached inside the patient.The procedure was completed and no additional patient complications were reported in relation to this event.

Event Description

It was reported that a component detachment occurred.While using a 10mm x 4.00mm wolverine coronary cutting balloon, the balloon and distal part of the catheter detached inside the patient.The procedure was completed and no additional patient complications were reported in relation to this event.Device evaluated by mfr: the device was received in two sections as the result of a break in the hypotube.A visual and tactile examination identified stretching and a complete break in the shaft polymer extrusion of the device.The break was located at hypotube to shaft polymer extrusion bond.The stretching of the shaft was noted to be located at the complete break and distal of the break.The hypotube was also noted to be kinked at several locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft or hypotube that may have contributed to the complaint incident.A microscopic examination identified damage to the tip.This type of damage is consistent with the device encountering resistance when attempting to cross a lesion.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 visual examination identified that the balloon was tightly folded which indicates that the balloon was not subjected to positive pressure.No issues were noted with the balloon that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Manufacturer Narrative

Date of event is unknown.The complaint was reported to bsc on 19-oct-2018.A date of (b)(6) 2018 was entered into the date of event field to indicate an unknown date in (b)(6) 2018.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 05:11 pm ct.The report number is being corrected from: 2134265-2018-64188 to: 2134265-2018-62770.

• 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
• MDR Report Key: 8070896
• MDR Text Key: 127139702
• Report Number: 2134265-2018-62770
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 11/22/2018
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1