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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 Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problem Perforation (2001)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the clip was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The proglide closure devices referenced are being filed under separate medwatch reports.
 
Event Description
This is filed to report the perforation and medical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, with a papillary muscle rupture. Right femoral vein was accessed and prepared with two pro glide closure devices prior to inserting the steerable guide catheter (sgc). The sgc was inserted into the vein over a non-abbott wire; however, resistance met during advancement. Fluoroscopy showed the proglide device was entangled on the sgc, causing the non-abbott wire to become kinked. It is unknown if the cause of resistance was the proglide closure devices or the non-abbott wire. The proglide devices were removed, and the sgc was removed over the wire. The non-abbott wire was cut with wire cutters and subsequently removed. A veinogram revealed the femoral vein had a small perforation. The perforation was bleeding and it was contained; pressure was applied to control bleeding. The sgc was flushed and re-advanced to the mitral valve to continue with the procedure. Two clips were implanted, reducing mr to 2. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8628047
MDR Text Key145647207
Report Number2024168-2019-03968
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/09/2020
Device Catalogue NumberSGC0301
Device Lot Number90108U233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/21/2019 Patient Sequence Number: 1
Treatment
(2) PROGLIDE CLOSURE DEVICES
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