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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7213
Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 09/20/2019
Event Type  Injury  
Event Description
It was reported that balloon rupture and difficulty removal were encountered.The target lesion was located in the mid left anterior descending artery (lad).A 2.75mm x 15mm nc emerge balloon catheter was selected for use.However, it was noted that the balloon popped and got stuck in the stent area of lad.Physician tried to use a guide extension catheter and pulled negative but the balloon was still unable to be removed from the vessel.After the balloon being pulled, the balloon detached and was stented to the vessel wall.No further complications reported.
 
Event Description
It was reported that balloon rupture and difficulty removal were encountered.The target lesion was located in the mid left anterior descending artery (lad).A 2.75mm x 15mm nc emerge balloon catheter was selected for use.However, it was noted that the balloon popped and got stuck in the stent area of lad.Physician tried to use a guide extension catheter and pulled negative but the balloon was still unable to be removed from the vessel.After the balloon being pulled, the balloon detached and was stented to the vessel wall.No further complications reported.It was further reported that the patient had complications and returned for surgery due to the balloon.
 
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 were numerous kinks.There was a complete separation near the hub and at the distal of the device.There was 121.1cm of the shaft and hypotube remaining from the proximal separation to the distal separation.The total remaining portion of the hypotube was 106.5cm measuring from the distal end of the hypotube to the proximal separation.The shaft on the distal end was stretched down for 17.6cm from the midshaft bond to the separation.There was contrast and blood in the inflation.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that balloon rupture and difficulty removal were encountered.The target lesion was located in the mid left anterior descending artery (lad).A 2.75mm x 15mm nc emerge balloon catheter was selected for use.However, it was noted that the balloon popped and got stuck in the stent area of lad.Physician tried to use a guide extension catheter and pulled negative but the balloon was still unable to be removed from the vessel.After the balloon being pulled, the balloon detached and was stented to the vessel wall.No further complications reported.It was further reported that the patient had complications and returned for surgery due to the balloon.
 
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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 Key9219065
MDR Text Key163178019
Report Number2134265-2019-12528
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846512
UDI-Public08714729846512
Combination Product (y/n)N
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0024177712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Date Manufacturer Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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