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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 04/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event. Additionally, a review of the complaint history identified no similar incidents reported from this lot. All available information was investigated and a definitive cause for the reported difficult to insert the steerable guide catheter (sgc) could not be determined. A definitive cause for perforation could not be determined. The reported hypotension was due to procedural circumstances. The reported patient effects of hypotension and perforation are listed in the mitraclip system instructions for use as 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.
 
Event Description
This is filed to report the perforation requiring intervention. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. During insertion of the steerable guide catheter (sgc), resistance was met and a kink was noted on the guide wire. The guide wire was retracted and the sgc was advanced again with minus applied. The patient became hemodynamically unstable and the systolic pressure went down due to a laceration at the right femoral access. The procedure was aborted. No clips were implanted and the mr remained at 4+. The laceration was treated with a covered stent and the patients blood pressure returned to normal. The cause of the laceration is unknown. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key8556856
MDR Text Key143295629
Report Number2024168-2019-03341
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
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2020
Device Catalogue NumberSGC0302
Device Lot Number90131U149
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 Received04/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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: 04/26/2019 Patient Sequence Number: 1
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