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

Model Number 3851

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Event date: first day of the month ((b)(6) 2019) from the bsc aware date was being populated as there was no given information about event date.

Event Description

It was reported that blade protrusion occurred.A 10 mm x 2.50 mm wolverine coronary cutting balloon was selected for use.During procedure, at inflation on high pressure, it was noted that the blade protruded at 18 and 20 atmospheres (atm).However, it was further reported that there were no part/fragment of the device left inside the patient.The device was simply pulled out from the patient's body.The procedure was completed with the original device used.The patient was good post procedure.

Manufacturer Narrative

B3 - event date: first day of the month ((b)(6) 2019) from the bsc aware date was being populated as there was no given information about event date.Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The initial inflation testing did not inflate the balloon, so the device was placed in a water bath.Upon removal from the water bath, it was attached to a boston scientific encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12atm(atmospheres) without issue.A vacuum was then applied.The inflation device was verified at 12atm, before and after use with a calibrated pressure gauge.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and tactile examination of the hypotube shaft was completed.No damage or any issues were noted with the hypotube that could have contributed to the complaint incident.A visual and tactile examination of the shaft polymer extrusion was completed.No damage or any issues were noted with the polymer extrusion shaft that could have contributed to the complaint incident.No damage or any issues were noted with the tip or markerbands that could have contributed to the complaint incident.There was no burrs or uneven edges observed on the markerbands.No damage or any issues were noted with the tip that could have contributed to the complaint incident.A visual and tactile examination of the balloon cutting blades were completed.Approximately 3mm of one of the cutting blades is detached and missing from the balloon surface at the proximal end of the balloon, the remaining section of the blade was undamaged and fully bonded to the balloon material.The complete pad of the blade remained fully bonded to the balloon material.The other two blades were intact and fully bonded to the balloon surface.No other damage was noted with the blades that could have contributed to the complaint incident.After the functional testing was completed it was observed that there was stretching of the inner lumen.It is likely that this damage occurred when the analyst inserted the guidewire through the tip because the initial as received photo does not appear to display any damage or stretching to the inner lumen.No other issues were noted during analysis.

Event Description

It was reported that blade protrusion occurred.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, at inflation on high pressure, it was noted that the blade protruded at 18 and 20 atmospheres (atm).However, it was further reported that there were no part/fragment of the device left inside the patient.The device was simply pulled out from the patient's body.The procedure was completed with the original device used.The patient was good post procedure.

• 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
• MDR Report Key: 9122595
• MDR Text Key: 160158947
• Report Number: 2134265-2019-11580
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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 Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023997310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1