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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE
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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE Back to Search Results
Catalog Number SGC0702
Device Problems Break (1069); Positioning Failure (1158); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report cable break.It was reported that during preparation, the steerable guide catheter (sgc) was prepared per the instructions for use.While preparing the guide for insertion, minus was applied to straighten the guide.However, after turning the knob in the minus direction, resistance was noted.The knob was turned back to neutral, then minus was again applied.Resistance was again felt, but this time, a rupture sounds was heard and is was suspected that a cable break occurred.The sgc was then unable to straighten; therefore, the device was not used and was replaced.There was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The returned device analysis confirmed the reported cable break resulting in positioning failure associated with inability to straighten the guide.Additionally, the reported resistance was also confirmed.The reported noise could not be replicated in a testing environment as it was likely a symptom of the cable break.The investigation determined that the physical resistance/sticking upon turning the knob was related to normal function of the device.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information provided and the results of the device analysis the reported physical resistance/sticking upon turning the knob was related to normal function of the device.The cable break resulting in positioning failure and noise appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.
 
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Brand Name
G4 STEERABLE GUIDING CATHETER
Type of Device
CATHETER, STEERABLE
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11542837
MDR Text Key243195271
Report Number2024168-2021-02210
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/15/2021
Device Catalogue NumberSGC0702
Device Lot Number01016U140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Date Manufacturer Received05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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