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

Model Number 7213

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/07/2019

Event Type  Injury  

Event Description

It was reported that balloon rupture and balloon detachment occurred.After a non-bsc wire passed through the lesion, a 2.25mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured and got separated.The patient was left lab on extracorporeal membrane oxygenation and was sent to coronary care unit.No further information available.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 1.5cm distal from the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.There was a circumferential tear 9mm from the proximal end of the balloon.The inner shaft was stretched down starting at the bicomponent weld and extending 19mm.The inner shaft was separated 139.6cm distal from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture and balloon detachment occurred.The multivessel percutaneous coronary intervention (pci) was performed with multiple stenosis to the left anterior descending (lad) artery, first diagonal branch (d1) and second obtuse marginal branch (om2).A pci was performed between the prox lad to mid lad.A non-bsc wire passed through the lesion, angioplasty was performed using a 2.25mm x 15mm nc emerge balloon catheter at 14 atmospheres for 15 seconds.However, the balloon ruptured and got separated.The physician deployed the 2.75mm x 32mm synergy drug-eluting stent to the affected area.Post-stent angioplasty was performed using a 3.00mm x 15mm nc emerge at 18 atmospheres for 10 seconds, but the balloon got stuck on the wire.Another non-bsc balloon was used for angioplasty and then the 2.5mm x 28mm synergy drug-eluting stent was deployed to overlap the first placed stent.Angioplasty was performed using a non-bsc balloon.There was a 0% residual stenosis post intervention.A pci was performed from the ostial first diagonal to the first diagonal branch (d1).A non-bsc wire passed through the lesion.Angioplasty was performed using a non-bsc balloon.A 2.25mm x 15mm nc emerge balloon catheter was advanced for dilatation at 18 atmospheres for 10 seconds.A 2.25mm x 38mm drug-eluting stent was successfully placed.Post-stent angioplasty was performed using a non-bsc balloon.The stent became thrombosed intraprocedure.Angioplasty was performed with a 2.0 x 12mm emerge balloon at 10 atmospheres for 12 seconds and a non-bsc balloon.The stent thrombosis was treated with balloon angioplasty.There was 0% residual stenosis post intervention.A pci was performed from the ostial om2 to om2 lesion.A non-bsc wire passed through lesion.The pre-interventional distal flow was normal (timi 3).Angioplasty were performed using a 2.25 x 15mm nc emerge balloon catheter at 10atmospheres for 15 seconds and two non-bsc balloons.Then a non-bsc stent was placed successfully.The post-interventional distal flow was decreased.There was a 99% residual stenosis post intervention.Multilevel pci to the lad, d1 and om2 was complicated by balloon shaft entrapment and severing.Lad stent thrombosis and cardiac arrest encountered.The cardiac arrest was treated with cardiopulmonary resuscitation, impella cp and extracorporeal membrane oxygenation (ecmo) and the patient was sent to the coronary care unit.Successful return of spontaneous circulation with ongoing ecmo support.It was further reported that a pci was performed on the 80% stenosed, 20mm long, target lesion between the proximal lad to mid lad, on the 90% stenosed target lesion located in the ostial first diagonal to the first diagonal branch (d1), and on the 95% stenosed target lesion located in the ostial om2 to om2 lesion.The shaft of the 2.25 nc emerge severed and was left in the patient's om2.Myocardial infarction, cardiogenic shock, and cardiac arrest were encountered.There was pulmonary hemorrhage secondary to anticoagulation and cpr.

Event Description

It was reported that balloon rupture and balloon detachment occurred.The multivessel percutaneous coronary intervention (pci) was performed with multiple stenosis to the left anterior descending (lad) artery, first diagonal branch (d1) and second obtuse marginal branch (om2).A pci was performed between the prox lad to mid lad.A non-bsc wire passed through the lesion, angioplasty was performed using a 2.25mm x 15mm nc emerge balloon catheter at 14 atmospheres for 15 seconds.However, the balloon ruptured and got separated.The physician deployed the 2.75mm x 32mm synergy drug-eluting stent to the affected area.Post-stent angioplasty was performed using a 3.00mm x 15mm nc emerge at 18 atmospheres for 10 seconds, but the balloon got stuck on the wire.Another non-bsc balloon was used for angioplasty and then the 2.5mm x 28mm synergy drug-eluting stent was deployed to overlap the first placed stent.Angioplasty was performed using a non-bsc balloon.There was a 0% residual stenosis post intervention.A pci was performed from the ostial first diagonal to the first diagonal branch (d1).A non-bsc wire passed through the lesion.Angioplasty was performed using a non-bsc balloon.A 2.25mm x 15mm nc emerge balloon catheter was advanced for dilatation at 18 atmospheres for 10 seconds.A 2.25mm x 38mm drug-eluting stent was successfully placed.Post-stent angioplasty was performed using a non-bsc balloon.The stent became thrombosed intraprocedure.Angioplasty was performed with a 2.0 x 12mm emerge balloon at 10 atmospheres for 12 seconds and a non-bsc balloon.The stent thrombosis was treated with balloon angioplasty.There was 0% residual stenosis post intervention.A pci was performed from the ostial om2 to om2 lesion.A non-bsc wire passed through lesion.The pre-interventional distal flow was normal (timi 3).Angioplasty were performed using a 2.25 x 15mm nc emerge balloon catheter at 10atmospheres for 15 seconds and two non-bsc balloons.Then a non-bsc stent was placed successfully.The post-interventional distal flow was decreased.There was a 99% residual stenosis post intervention.Multilevel pci to the lad, d1 and om2 was complicated by balloon shaft entrapment and severing.Lad stent thrombosis and cardiac arrest encountered.The cardiac arrest was treated with cardiopulmonary resuscitation, impella cp and extracorporeal membrane oxygenation (ecmo) and the patient was sent to the coronary care unit.Successful return of spontaneous circulation with ongoing ecmo support.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 1.5cm distal from the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.There was a circumferential tear 9mm from the proximal end of the balloon.The inner shaft was stretched down starting at the bicomponent weld and extending 19mm.The inner shaft was separated 139.6cm distal from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 1.5cm distal from the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.There was a circumferential tear 9mm from the proximal end of the balloon.The inner shaft was stretched down starting at the bicomponent weld and extending 19mm.The inner shaft was separated 139.6cm distal from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture and balloon detachment occurred.After a non-bsc wire passed through the lesion, a 2.25mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured and got separated.The patient was left lab on extracorporeal membrane oxygenation and was sent to coronary care unit.No further information available.

• 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: 9235053
• MDR Text Key: 163838573
• Report Number: 2134265-2019-12704
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846499
• UDI-Public: 08714729846499
• Combination Product (y/n): N
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0022861665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR