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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 08/08/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number (b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the steerable guiding catheter leak.It was reported that during preparation of the steerable guiding catheter (sgc), while trying to insert the dilator into the sgc, the hemostatic valve failed to hold column.After repeating dilator insertion three times, the hemostatic valve water level still dropped.The sgc was not used, no patient involvement.A new sgc was used to continue the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Exemption number e2019001.The device was returned and investigated.The returned device analysis did not confirm the reported leak issue as a leak was not noted during returned device analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported leak could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
STEERABLE GUIDE CATHETER
Type of Device
VALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key8938181
MDR Text Key168688558
Report Number2024168-2019-11244
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/06/2019
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 Date03/24/2020
Device Catalogue NumberSGC0302
Device Lot Number90325U127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2019
Initial Date Manufacturer Received 08/08/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received08/29/2019
Supplement Dates FDA Received09/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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