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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 Problems Difficult To Position (1467); Device Slipped (1584)
Patient Problem Atrial Perforation (2511)
Event Date 05/29/2018
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 device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report the torn septum. It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr). There were difficulties maneuvering due to the floppy septum. The steerable guide catheter (sgc) was slipping out of position in the atrium. The first clip delivery system (cds) was inserted, but it was removed with the unemployed mitraclip after the shaft was noted to have become twisted during maneuvering. The procedure continued with another cds and two mitraclips were implanted reducing mr to grade 3 to 4; however, it was a very long procedure. After removal of the sgc, the septum was noted to have torn. There have been no patient symptoms related to the septal tear. No treatment has been planned for the tear. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Review of the complaint history identified no other incidents reported from this lot. The investigation determined the reported slippage of the device and difficulty positioning the device appears to be related to the floppy septum. The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures and appears to be a result of procedural conditions (retrieving the steerable guide catheter). There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key7616180
MDR Text Key111616347
Report Number2024168-2018-04639
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
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 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/20/2019
Device Catalogue NumberSGC0302
Device Lot Number80219U248
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 Received08/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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: 06/19/2018 Patient Sequence Number: 1
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