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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 Difficult to Insert (1316)
Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Event Date 03/04/2019
Event Type  Death  
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.
 
Event Description
This is filed to report the perforation resulting in death. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. During insertion of the steerable guide catheter (sgc), resistance was felt and the physician thought there was a kink in the guide wire. A second attempt was made to insert the sgc with minus applied and the sgc was able to advance to the left atrium (la) with no issue. When the dilator and guide wire were removed, the patients blood pressure decreased. The sgc was removed and a perforation was noted on the iliac vein. A balloon catheter was used in the attempt to stop the bleeding and then an attempt was made to clamp off the vein however the patient died due to the laceration to the vein. In the physicians opinion, the sgc contributed to the perforation of the vein. No additional information was provided.
 
Manufacturer Narrative
(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 for difficult to remove the steerable guide catheter (sgc) from this lot. All available information was investigated, and a definitive cause for the reported difficult to insert the sgc into the patient anatomy could not be determined in this incident. The reported perforation appears to be due to operational context (procedural circumstances) and the reported hypotension appears to be the cascading effect of the observed perforation. The reported death appears to be due to procedural circumstances of laceration of the vein. The reported adverse event/patient effect of hypotension, vessel perforation and death as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures. There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.
 
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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 Key8447788
MDR Text Key139687943
Report Number2024168-2019-02273
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
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 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/13/2019
Device Catalogue NumberSGC0302
Device Lot Number81113U219
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 Received05/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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: 03/25/2019 Patient Sequence Number: 1
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