MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number H74939401102000

Device Problems Hole In Material (1293); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: a visual examination of the returned device identified that the balloon was unfolded which indicates that the balloon was subjected to positive pressure.Solidified saline solution was noted within the balloon material.The returned device was attached to an encore inflation unit and positive pressure was applied.The balloon could not be inflated due to the presence of solidified saline solution within the balloon and inflation lumen.The device was soaked in a water bath to help soften the solidified saline solution before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied when liquid was noted escaping from a balloon pinhole leak 2mm distal to the distal edge of the proximal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.The markerbands, blades 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.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple kinks along the length of the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a balloon rupture and pinhole occurred.The 80% stenosed, 12-15mm long target lesion was located in the moderate tortuousity and moderate calcified left circumflex artery.A 10mmx2.00mm wolverine¿ coronary cutting balloon® monorail® was advanced and inflated three times to 12 atmospheres for 15-20 second.On the third inflation, the balloon ruptured.It was believed an old previously placed stent or a piece of calcium may have punctured the balloon causing it to rupture.A 2.5mm x 12mm nc emerge was used to dilate the lesion one more time and then a synergy stent was deployed.Post dilation was performed and the procedure was completed with excellent outcomes.There were no patient complications reported and the patient status is fine.

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: a visual examination identified that the balloon was unfolded which indicates that the balloon was subjected to positive pressure.Solidified saline solution was noted within the balloon material.The returned device was attached to an encore inflation unit and positive pressure was applied.The balloon could not be inflated due to the presence of solidified saline solution within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified saline solution before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied when liquid was noted escaping from a balloon pinhole leak 2mm distal to the distal edge of the proximal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.The markerbands, blades 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.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple kinks along the length of the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a balloon rupture and pinhole occurred.The 80% stenosed, 12-15mm long target lesion was located in the moderate tortuousity and moderate calcified left circumflex artery.A 10mmx2.00mm wolverine¿ coronary cutting balloon® monorail® was advanced and inflated three times to 12 atmospheres for 15-20 second.On the third inflation, the balloon ruptured.It was believed an old previously placed stent or a piece of calcium may have punctured the balloon causing it to rupture.A 2.5mm x 12mm nc emerge was used to dilate the lesion one more time and then a synergy stent was deployed.Post dilation was performed and the procedure was completed with excellent outcomes.There were no patient complications reported and the patient status is fine.

• Brand Name: WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7283501
• MDR Text Key: 100666647
• Report Number: 2134265-2018-01043
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888222
• UDI-Public: 08714729888222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020/S072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 11/08/2019
• Device Model Number: H74939401102000
• Device Catalogue Number: 39401-10200
• Device Lot Number: 21358600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR