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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 SGC0302
Device Problem Break (1069)
Patient Problem Mitral Regurgitation (1964)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned. All available information was investigated the reported cable break and resultant tip deflection issue were confirmed via returned device analysis. The reported noise could not be replicated in the testing environment as the event was a symptom of the cable break. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents from the lot. The investigation determined that the reported noise and mechanical issue of inability to deflect the tip were a result of the cable break; however, a definitive cause for the cable break could not be definitively determined. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the previously filed report, the following information was provided. The reported slight resistance felt during advancement was not more than usual. No additional information was provided.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the steerable guide catheter (sgc) cable break. It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with a grade of 3-4. When attempting to cross to the septum with the sgc, slight resistance was felt due to the anatomy. When turning the +/- knob to straighten the guide, a "ping" sound was heard and the tip was no longer responding. A cable break occurred. The sgc was removed and was replaced. One clip was implanted reducing mr to <1. There were no adverse patient effects. The patient is well. 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 Key7072257
MDR Text Key246001011
Report Number2024168-2017-09283
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeNL
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 12/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2018
Device Catalogue NumberSGC0302
Device Lot Number70622U213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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