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 Device-Device Incompatibility (2919); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The wolverine device was received and analyzed.A visual and microscopic examination was performed on the returned balloon material.The balloon material was returned partially unfolded and inflation medium was noted within the balloon material which indicates the balloon had been subjected to positive pressure.As the balloon had been utilized, the investigator reviewed an image of the balloon which was taken during unpacking, the proximal balloon folds appeared relaxed which may have occurred when the balloon protector was removed from the device.No damage or any issues were noted with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination was performed on the blades of the returned device.It was noted that a section of one of the blades approximately 1mm in length was lifted from the mid-section of the balloon material.The damage can potentially be a result of the resistance encountered during withdrawal of the device.The pad was intact and the remainder of the blade undamaged and fully bonded to the balloon material.All other blades and pads were undamaged and fully bonded to the balloon material.No issues were noted with either the blades or pads that could have contributed to the detachment from the balloon material.A visual and microscopic examination identified no damage or any issues with the tip or markerbands or shaft of the returned device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that the balloon blade was bent.The target lesion was located in mid and distal right coronary artery.A 10mmx3.2mm wolverine coronary cutting balloon monorail was selected fo use.During preparation, it was noted that the proximal side of the balloon was already inflated.There were no issues when applying a vacuum to the device or removing the balloon protector.Subsequently, the device was still used during the procedure and no problem was noted when passing through the lesion and during inflation.However, the balloon became caught in the stent when it was removed after deflation., furthermore, it was noted that the blade got bent in "u" shape from the flex point in the middle.No resistance was felt while removing the balloon.The device was removed with a non bsc guide catheter.No patient complications were reported.However, device analysis revealed a section of one of the blades approximately 1mm in length was lifted from the mid-section of the balloon material.

• 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: 8549308
• MDR Text Key: 143058320
• Report Number: 2134265-2019-04288
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 22766686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• 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