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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 Mechanical Problem (1384); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned for 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 other incidents reported from this lot. All available information was investigated and a definitive cause for the reported bent steerable guide catheter (sgc) shaft resulting in difficulty positioning the clip delivery system (cds) could not be determined. Additionally, a definitive cause for the reported loss of tip deflection could not be determined. The reported resistance encountered during cds advancement through the sgc (difficult to position); however, appears to be a secondary effect of the bent sgc shaft. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The steerable guide catheter is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the inability to straighten the steerable guide catheter (sgc). It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. After preparation of the sgc, the minus knob was applied, and the device was advanced to the left atrium. While advancing the clip delivery system (cds), the sgc appeared to have an additional bend. It looked like plus had been added to the device. The +/- knob was rotated to confirm that the knob was in neutral. The cds was advanced out of the sgc with noted resistance, and the clip was deployed. The cds and sgc were retracted to the right atrium together. The minus knob was applied to retract the sgc out of the groin; however, the sgc did not straighten. The cds and sgc were removed from the patient without any issue or increased resistance. No injury to the patient was noted. One clip was implanted, reducing the mr to 1+. There were no adverse patient effects and 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 Key6963658
MDR Text Key247222381
Report Number2024168-2017-08353
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/20/2018
Device Catalogue NumberSGC0301
Device Lot Number70619U127
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 Received11/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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