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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 7161
Device Problems Inflation Problem (1310); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and balloon.The inflation lumen was bubbled and stretched out for 4mm in length and 72mm from the tip of the device.The balloon was loosely folded and there was tip damage to the device.After soaking the device to remove contrast, an inflation device was connected to the inflation port.The device was inflated to 4 atmospheres (atm) to see if there was a leak in the inflation lumen where the lumen was bubbled up and stretched.Functional testing revealed shaft damage and a longitudinal shaft tear in the inflation lumen 4mm in length and 72mm from the tip of the device.The device failed to inflate to rated burst pressure as at 4atm the device was found to be leaking.
 
Event Description
Reportable based on device analysis completed on 01-sep-2021.It was reported that balloon slow inflation and shaft damage occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the left circumflex artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.The balloon was inflated 12 times.On the 7th inflation at 18 atmospheres for 10 seconds, the physician noticed that when inflating, the balloon did not expand at the marker and inflated at the proximal shaft of the catheter.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed longitudinal shaft tear.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12510474
MDR Text Key272687469
Report Number2134265-2021-11353
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 09/21/2021
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 Health Professional
Device Expiration Date05/12/2023
Device Model Number7161
Device Catalogue Number7161
Device Lot Number0026009326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2021
Initial Date FDA Received09/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age53 YR
Patient Weight37
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