MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493926720350

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Death (1802); Rupture (2208); Loss Of Pulse (2562)

Event Date 05/06/2020

Event Type  Death  

Event Description

From staff: patient was in cardiac catheterization lab for cardiac intervention and stenting of the vein graft to obtuse marginal artery.Following the stent placement, the vein graft was post dilated with a 3.5 x 20 mm nc emerge balloon.According to the physician report the balloon was not able to be retrieved from the vein graft when the rail was removed.Multiple interventions were tried to retrieve the balloon without success.Op report: the balloon was inflated to high pressure.After deflation the balloon could not be retracted easily but with guiding catheter repositioning and back tension, the balloon delivery catheter was able to be removed however, the balloon itself was retained within saphenous vein graft (svg).Wire position was also lost at that time.Reseating of the guide and angiography demonstrated rupture of the svg within the stented portion.A prowater was reintroduced into the vessel but could not be passed beyond the previously stented portion.A new 3.5 mm balloon was introduced into the proximal vein graft to tamponade the bleed.Heparin was reversed with protamine.A 0.014 x 180 cm prowater wire was placed across the lesion.Balloon angioplasty.A 3.5 mm (d) x 20 mm (l), emerge balloon was employed.The balloon was placed across the lesion and given a single inflation with a maximum inflation pressure of 20 atm.The balloon was left inflated while the patient underwent cardiopulmonary resuscitation.Anesthesia was called and patient was intubated and placed on ventilator.The patient underwent several cycles of cpr and several rounds of epinephrine.Emergent venous access was obtained and levophed and dopamine were initiated.The patient developed pulseless electrical activity and had a resuscitation effort of 20 minutes.Time of death 1344.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10082637
• MDR Text Key: 191843999
• Report Number: 10082637
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926720350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 31390 DA
• Patient Weight: 87