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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 Device Operates Differently Than Expected (2913); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The sgc was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The cds referenced is filed under a separate medwatch report number.
 
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 4. The sgc was advanced to the left atrium. When the clip delivery system (cds) was advanced for straddling, the sgc needed to be turned over 180 degrees to get a normal fluoroscopy view. It was determined that the sgc had an abnormal angle; therefore, the decision was made to replace the device. During removal of the cds, resistance was noted with the sgc tip. The cds was advanced back and forth a few times, and the cds was removed. The sgc was then removed, and it was noted that the soft tip was torn. A new sgc was successfully used with the same cds. Two clips were implanted, reducing the mr to 1. There was no clinically significant delay and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The steerable guide catheter (sgc) was returned and investigated. The reported device operates differently than expected issue in this incident could not be confirmed; however, the reported torn material sgc soft tip was confirmed. A review of the lot history record revealed no manufacturing nonconformities issued to this lot. Additionally, a review of the complaint history identified no similar incidents reported from this lot. A definitive cause for the reported device operates differently than expected could not be confirmed as the return device analysis confirmed that the sgc functioned as intended. Additionally, the reported torn soft tip appears to be related to user technique/procedural conditions as the clip delivery system was advanced back and forth a few times resulting in the clip getting caught on the tip of the sgc, tearing the sgc tip. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
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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 Key6380669
MDR Text Key69367999
Report Number2024168-2017-01836
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
Report Date 03/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2017
Device Catalogue NumberSGC0301
Device Lot Number61202U150
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
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: 03/06/2017 Patient Sequence Number: 1
Treatment
MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
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