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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX FLEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION APEX FLEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7508
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Used the first day of the month of aware date as no event date was provided.
 
Event Description
It was reported that catheter entrapment occurred.A 1.50mm x 20mm apex flex balloon catheter was advanced for dilatation.However, the balloon was unable to be advanced nor pull back from the wire.Both balloon and guidewire were removed from patient's body as a unit.No patient complications were reported.
 
Event Description
It was reported that catheter entrapment occurred.A 1.50mm x 20mm apex flex balloon catheter was advanced for dilatation.However, the balloon was unable to be advanced nor pull back from the wire.Both balloon and guidewire were removed from patient's body as a unit.No patient complications were reported.
 
Manufacturer Narrative
Used the first day of the month of aware date as no event date was provided.Device evaluated by mfr.:returned product consisted of an apex balloon catheter with a non-bsc 0.014 inch guidewire in the lumen.The hub, shafts, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The balloon was tightly folded.Inspection of the device revealed that the wire lumen shaft was buckled in the hub of the device with the wire lumen wavy for 18cm distal of the hub.The outer shaft was stretched 97cm distal of the hub to the proximal end of the balloon.A measurement of the shaft was not able to be performed with the shaft being stretched.The guidewire used in the procedure was received stuck inside the complaint device.An attempt to remove the guidewire was unsuccessful, as it was stuck on wire due to the buckled and stretched wire lumen shaft.The damage to the wire lumen shaft is consistent to damage caused by the guidewire during advancement or removal.
 
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Brand Name
APEX FLEX
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9678487
MDR Text Key179245592
Report Number2134265-2020-00948
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729475095
UDI-Public08714729475095
Combination Product (y/n)N
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/15/2021
Device Model Number7508
Device Catalogue Number7508
Device Lot Number0023195619
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE WIRE: COMMAND ES; GUIDE WIRE: COMMAND ES
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