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

Model Number	7214
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Death (1802); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Date of death: (b)(6) 2020.Date of event: used the 1st day of the month of (b)(6) 2020 as event date provided was (b)(6)2020.
Event or Problem Description
It was reported that balloon removal difficulties were encountered and the patient died.The target lesion was located in the vein graft to obtuse marginal artery.After a stent was deployed, a 3.50mm x 20mm nc emerge balloon catheter was advanced for post-dilation.The balloon was inflated to high pressure and after deflation, the balloon could not be easily retracted but with guiding catheter repositioning and back tension, the balloon delivery catheter was able to removed; however, the balloon itself was retained within saphenous vein graft (svg).Wire position was also lost and reseating of the guide and angiography demonstrated rupture of the svg within the stented portion.A different manufactures guide wire was reintroduced into the vessel but could not be passed beyond the previously placed stent.A new 3.5x20mm emerge balloon catheter was introduced into the proximal vein graft to tamponade the bleed and heparin was reversed with protamine.After a different manufacturers 0.014 x 180cm guide wire was used to cross the lesion, a 3.5mm x20mm emerge balloon catheter was advanced and inflated at 20 atmospheres.The balloon was left inflated while the patient underwent cardiopulmonary resuscitation (cpr).Anesthesia was given 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; however, the patient died.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10368442
• Report Number: 2134265-2020-09888
• Device Sequence Number: 19587523
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0025333008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 86 YR
• Patient Weight: 87