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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 H7493918912300
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon pinhole occurred.A 3.00mm x 12mm emerge balloon catheter was advanced for dilation.However, when the balloon was inflated, the balloon did not inflate and it was noted that the balloon had a hole.No patient complications were reported.
 
Event Description
It was reported that balloon pinhole occurred.A 3.00mm x 12mm emerge¿ balloon catheter was advanced for dilation.However, when the balloon was inflated, the balloon did not inflate and it was noted that the balloon had a hole.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The balloon was loosely folded.There was blood in the inflation lumen.The tip, balloon, markerbands, and inner/outer shafts were microscopically and tactile inspected.Inspection revealed inner shaft damage (perforation) that was located 441 mm from the tip of the device, numerous kinks in the distal shaft and kinks in the hypotube located 2.5 cm and 34 cm from the strain relief.An inflation device (filled with water) was attached to the hub of the emerge, and when positive pressure was applied, water was found to be streaming from the tip of the device and the balloon could not retain pressure.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The balloon was loosely folded.There was blood in the inflation lumen.The tip, balloon, markerbands, and inner/outer shafts were microscopically and tactile inspected.Inspection revealed inner shaft damage (perforation) that was located 441 mm from the tip of the device, numerous kinks in the distal shaft and kinks in the hypotube located 2.5 cm and 34 cm from the strain relief.An inflation device (filled with water) was attached to the hub of the emerge, and when positive pressure was applied, water was found to be streaming from the tip of the device and the balloon could not retain pressure.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
 
Event Description
It was reported that balloon pinhole occurred.A 3.00mm x 12mm emerge¿ balloon catheter was advanced for dilation.However, when the balloon was inflated, the balloon did not inflate and it was noted that the balloon had a hole.No patient complications were reported.
 
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Brand Name
EMERGE¿
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key7632322
MDR Text Key112196474
Report Number2134265-2018-05842
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,health
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/02/2021
Device Model NumberH7493918912300
Device Catalogue Number39189-1230
Device Lot Number22089490
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Date Manufacturer Received07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age87 YR
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