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

Model Number UNK854

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Death (1802)

Event Date 04/09/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-04869.It was reported that shaft separation, froze on wire, and patient death occurred.The target lesion was located in the tightly stenosis and very tightly calcified proximal left anterior descending artery.The target lesion was ballooned and at this point the vessel goes down with thrombolysis in myocardial infarction (timi) 0 flow.A 3.50mm diameter synergy¿ drug-eluting stent was implanted.The physician was going in to post-dilate the lesion with a 3.50 x 8 nc emerge® balloon catheter but it was stuck on a non-bsc guidewire.The catheter separated from the balloon and the balloon markers remained on the wire behind the bound up balloon material that was stuck on the wire.Flow never returned to the artery and they did not want to pull everything out because cardiopulmonary resuscitation was initiated.A second wire was attempted, but code continued.Patient passed away on the table.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7571611
• MDR Text Key: 110161881
• Report Number: 2134265-2018-04870
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• 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
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death