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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 SGC0303
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Dizziness (2194)
Event Date 09/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was discarded. Investigation is not complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This report is filed for right groin bleeding post procedure. It was reported that on (b)(6) 2018 two mitraclips were implanted, without reported issue, reducing the mitral regurgitation (mr) from severe to mild. That same day while lying flat on the bed, the patient's systolic blood pressure was in the 90's to low 100's and then dropped into the 70's. The patient experienced dizziness and bleeding from the right groin with oozing noted. One liter of normal saline bolus was provided. The patient's blood pressure improved however would intermittently drop again. Two units of packed red blood cells were provided and pressure was held for 30 minutes on the right groin. The bleeding resolved. The event required prolonged hospitalization. The patient was discharged from the hospital on (b)(6) 2018. No additional information was provided regarding this issue.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. It should be noted that the reported patient effects of hemorrhage requiring transfusion, hypotension and dizziness, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures. Based on the information reviewed, a definitive cause for the reported hemorrhage could not be determined in this case. The reported hypotension and dizziness appears to be the secondary effects of the reported hemorrhage as blood was noted to be oozing at the right groin. Based on the information reviewed, 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 Key7995357
MDR Text Key124699263
Report Number2024168-2018-08102
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 health professional,study
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/04/2019
Device Catalogue NumberSGC0303
Device Lot Number80104U144
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 Received12/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2018
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: 10/23/2018 Patient Sequence Number: 1
Treatment
2 IMPLANTED MITRACLIPS
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