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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 Problems Sticking (1597); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The clip delivery system device is being filed under separate medwatch reports. Evaluation summary: the steerable guiding catheter (sgc) was returned and the reported sgc torn soft tip was confirmed. A review of the lot history record revealed no manufacturing nonconformities in this lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. All available information was investigated and the reported clip getting caught on the guide tip, resulting in the identified tears in the soft tip appears to be related to user technique during positioning and straddling. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.
 
Event Description
This is filed to report the steerable guiding catheter (sgc) soft tip tear. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4. During straddling and positioning of the clip delivery system (cds) the clip became stuck at the tip of the sgc. After the clip was free the sgc and the cds were gently removed and replaced with a new sgc and cds. The tip of the sgc was observed to be torn. There were no adverse patient effects and 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 Key6428548
MDR Text Key70987428
Report Number2024168-2017-02437
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 03/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2017
Device Catalogue NumberSGC0302
Device Lot Number61015U137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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: 03/23/2017 Patient Sequence Number: 1
Treatment
MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
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