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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 7171
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that shaft hole/perforation occurred.The target lesion as located in the septal artery.A 1.50mm x 12mm emerge balloon catheter was advanced for dilatation over the guidewire.However, it was noted that the "wire came out from the outside of otw balloon".The physician felt uncomfortable using the device so it was exchanged for another 1.50mm x 12mm emerge balloon catheter and the procedure was completed.No patient complications were reported.
 
Event Description
It was reported that shaft hole/perforation occurred.The target lesion as located in the septal artery.A 1.50mm x 12mm emerge balloon catheter was advanced for dilatation over the guidewire.However, it was noted that the "wire came out from the outside of otw balloon".The physician felt uncomfortable using the device so it was exchanged for another 1.50mm x 12mm emerge balloon catheter and the procedure was completed.No patient complications were reported.Returned product consisted of an emerge balloon catheter with a syringe.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed that the tip is damaged.There is blood present in the guide wire lumen and hub.The balloon was loosely folded prior to inflation testing.The guide wire used in the clinical procedure was not returned with the device.The test guide wire was advanced into the guide wire lumen and was able to pass through.The device was also pressure tested to find any possible leaks.The balloon was inflated and could hold pressure for 5 minutes.Inspection of the remainder of the device presented no other damage or irregularities.
 
Manufacturer Narrative
Age at time of event: 18 years or older.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 11:55 am ct.The report number is being corrected from: 2134265-2018-64061to: 2134265-2018-63067.
 
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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 Key8101769
MDR Text Key128276178
Report Number2134265-2018-63067
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K083094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/24/2019
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 Date09/16/2020
Device Model Number7171
Device Catalogue Number7171
Device Lot Number0022665132
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2018
Initial Date Manufacturer Received 10/31/2018
Initial Date FDA Received11/26/2018
Supplement Dates Manufacturer Received11/28/2018
Supplement Dates FDA Received01/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight62
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