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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493919320250
Device Problem Material Rupture (1546)
Patient Problems Intimal Dissection (1333); Cardiac Arrest (1762)
Event Date 08/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a percutaneous coronary interventional treatment procedure a balloon rupture and dissection occurred. The 80% stenosed lesion was located in the mildly calcified and mildly tortuous lad (left anterior descending). The 2. 5x20mm emerge balloon passed the lesion easily. During dilation there was a pressure loss at 6 atm. A dissection occurred from the left main (lm) into the aorta. The patient was "reanimated" with manual pumping after 20 seconds. The dissection was treated with stent placement from the lm to lad. There were no long term complications for the patient. A small hole was noted in the balloon.
 
Manufacturer Narrative
Device evaluated by mfr: returned device consisted of an emerge balloon catheter. The balloon was loosely folded, with blood and contrast in the balloon and lumen. The balloon, markerbands and proximal weld were microscopically inspected. Inspection revealed a pinhole in the balloon material, located at the distal edge of the proximal markerband. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
It was reported that during a percutaneous coronary interventional treatment procedure a balloon rupture and dissection occurred. The 80% stenosed lesion was located in the mildly calcified and mildly tortuous lad (left anterior descending). The 2. 5x20mm emerge balloon passed the lesion easily. During dilation there was a pressure loss at 6 atm. A dissection occurred from the left main (lm) into the aorta. The patient was "reanimated" with manual pumping after 20 seconds. The dissection was treated with stent placement from the lm to lad. There were no long term complications for the patient. A small hole was noted in the balloon.
 
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Brand NameEMERGE¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5947379
MDR Text Key54626711
Report Number2134265-2016-07964
Device Sequence Number1
Product Code LOX
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberH7493919320250
Device Catalogue Number39193-2025
Device Lot Number0019357538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/13/2016 Patient Sequence Number: 1
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