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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 SGC0301
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Estimated weight. The steerable guiding catheter (sgc) was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system (cds) referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.
 
Event Description
This is filed to report the resistance noted between the delivery system and the steerable guiding catheter (sgc). It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The sgc was advanced to the left atrium. The clip delivery system (cds) was then advanced through the sgc. When the clip was approximately 10 cm out of the soft tip of the sgc, an unusual amount of resistance was met, and the cds became stuck. The cds was unable to be retracted into the sgc, so the cds and sgc were removed together as a unit. The closed, undeployed clip met resistance at the interatrial septum, but was able to be removed. This resulted in a large atrial septal defect (asd). Dopamine was administered to treat the patient's low blood pressure. Septal tissue was noted on the undeployed clip. A new sgc and cds were used. One clip was successfully implanted, reducing the mr to 1. An amplatzer septal plug was implanted to treat the asd. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was returned for analysis and abbott vascular (av) confirmed the reported resistance between the clip delivery system (cds) and the steerable guide catheter (sgc), and determined it was related to a deformed tip ring on the sgc. Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint. A search of the complaint handling database was performed and there were no other complaints identified from this lot. Further assessment per site operating procedures was performed and identified a potential product deficiency related to the manufacture of the device. The assessment indicates that this is an isolated incident and there is no evidence to indicate that a wider population of product is impacted. Av will continue to trend the performance of these devices.
 
Manufacturer Narrative
(b)(4). Correction: (b)(4) device coding was added back to report.
 
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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 Key6425777
MDR Text Key70883018
Report Number2024168-2017-02409
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 company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2017
Device Catalogue NumberSGC0301
Device Lot Number61207U222
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
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: 03/22/2017 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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