MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC, EMERGE PUSH

Model Number GTIN 08714729806608

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2017

Event Type  Injury  

Event Description

A 1.5 cm diameter coronary balloon ruptured and fragmented in the patient during the case.A small balloon fragment with a radiopaque marker was retained.The fragment was captured with a stent and stented to the wall of the artery.No risk of further embolization.These findings were discussed at length with the patient's family following the procedure.Initial left carotid angiogram: the initial left carotid angiogram demonstrates complete occlusion at the level of the carotid bulb.In addition, a 90-95 percent stenosis involving the origin of the left common carotid artery is demonstrated.Post cervical internal carotid artery stenting: the cervical carotid stenosis-associated with the carotid bulb, successfully treated with a 7 mm diameter stent dilated to 5mm.Additional stent was placed above in order to trap a balloon fragment which detached from a 1.5 cm diameter coronary balloon during 3 stenting dilatation of the left carotid bulb.Post stenting of left common carotid artery stenosis: a new stent is identified across the origin of the left common carotid artery.A residual mild stenosis is present.The stent is appropriately positioned with its waits at the origin.Brisk flow demonstrated.Left internal carotid arteriography status post stenting: the intracranial left internal carotid artery is normal.The anterior middle cerebral arteries are normal.Minimally delayed filling of the posterior parietal distal branches is demonstrated.Query spasm.The remainder of the blood flow to the left anterior circulation is normal.Findings are consistent with restoration of tici 2b flow.Right pelvic arteriogram: moderate to severe atherosclerotic change with bulky plaque involving the right common femoral artery demonstrated.This is not favorable for angio-seal deployment.

• Brand Name: BOSTON SCIENTIFIC, EMERGE PUSH
• Type of Device: EMERGE PUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 6568716
• MDR Text Key: 75328196
• Report Number: MW5069799
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2017

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: No Information
• Device Model Number: GTIN 08714729806608
• Device Catalogue Number: H749391921215O
• Device Lot Number: 20211256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR