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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7134
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
Event Type  malfunction  
Event Description
It was reported that removal difficulties were encountered.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified mid left anterior descending artery.A 2.50mm x 20mm emerge balloon catheter was advanced for post-dilatation of a non-bsc implanted stent.The emerge balloon catheter was fully deflated prior withdrawal.Resistance was felt during withdrawal.The non-bsc implanted stent migrated from the target lesion.Additional stenting was required as a result of the migrated non-bsc stent.There were no patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely tightly folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 18mm long starting 3mm proximal from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that removal difficulties were encountered.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified mid left anterior descending artery.A 2.50mm x 20mm emerge balloon catheter was advanced for post-dilatation of a non-bsc implanted stent.The emerge balloon catheter was fully deflated prior withdrawal.Resistance was felt during withdrawal.The non-bsc implanted stent migrated from the target lesion.Additional stenting was required as a result of the migrated non-bsc stent.There were no patient complications reported and the patient's status was stable.
 
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Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11483710
MDR Text Key239748059
Report Number2134265-2021-02367
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729806325
UDI-Public08714729806325
Combination Product (y/n)N
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/08/2022
Device Model Number7134
Device Catalogue Number7134
Device Lot Number0024745348
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Date Manufacturer Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
Patient Weight65
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