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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 SGC0301
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned. All available information was investigated and the reported detachment of device component (dilator rhv cap) was confirmed. Additionally, the rhv was observed to be broken. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. The investigation was unable to determine a definitive cause for the reported rhv cap detachment and broken rhv. There is no indication of a product quality issue with respect to manufacture, design, or labeling.
 
Event Description
It was reported that the cap of the rotating hemostatic valve (rhv) on the dilator was closed and flushed without issue. When the cap was being turned to open, the cap fell off. Attempt was made to screw the cap back on, but was not able to be re-attached. There was no patient involvement. Another dilator was used to complete the procedure. No additional information was provided. Analysis of the returned device identified the hemostatic valve was broken at the y connector.
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9291180
MDR Text Key174670246
Report Number2024168-2019-13316
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Catalogue NumberSGC0301
Device Lot Number90727U211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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