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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0301
Device Problems Break (1069); Positioning Failure (1158)
Patient Problem No Patient Involvement (2645)
Event Date 03/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
 
Event Description
This report is filed as a cable break occurred.It was reported that during steerable guide catheter (sgc) preparation, too much (b)(6) was applied and the cable broke.There was no sgc tip deflection noted following.The device was discarded and not used.There was no patient involvement.No additional information was provided regarding this device issue.
 
Manufacturer Narrative
Internal file number : (b)(4).The device was not returned for analysis.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 similar incidents reported from this lot.The investigation determined that the reported mechanical issue of unable to curve guide was a result of the cable break.The cable break appears to be related to the user technique.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of Device
STEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key8500076
MDR Text Key141480663
Report Number2024168-2019-02771
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,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/03/2019
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 Date10/24/2019
Device Catalogue NumberSGC0301
Device Lot Number81024U112
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received04/10/2019
Supplement Dates Manufacturer Received04/26/2019
Supplement Dates FDA Received05/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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