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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 or Delayed Positioning (1157)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Event Date 04/09/2019
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 steerable guide catheter 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 hemorrhage, perforation and medical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4. The right femoral vein was punctured, and the steerable guide catheter (sgc) was advancing; however, resistance met with the inguinal ligament within the abdominal wall. The sgc was removed, and a small incision was made to re-insert the sgc into the left atrium. Then the clip delivery system (cds) was advanced to the mitral valve; and the clip was deployed, reducing mr. The blood pressure was gradually dropping immediately after implanting the clip (the gripper line was removed without resistance and problem); and therefore, the cds and the sgc were removed. The blood pressure dropped to 30 and manual compressions were performed. The physician stated that cardiac fluid leakage was not checked at the time, but due to the use of medium contrast and confirming the puncture site, leakage of the intraperitoneal blood was due to the perforation at the right femoral vein and low blood pressure which was possibly caused by the sgc. The leakage was treated with a suture. One clip was implanted, reducing mr to 1. On (b)(6) 2019, the blood pressure and hemodynamic status was stable. 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 Key8574425
MDR Text Key143857251
Report Number2024168-2019-03481
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/24/2019
Device Catalogue NumberSGC0302
Device Lot Number80723U231
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 Received05/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2018
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: 05/02/2019 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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