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Catalog Number SGC0101
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The steerable guide catheter was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The clip delivery system referenced is being filed under a separate medwatch mfr number.
Event Description
This is filed to report difficulty retracting the clip into the steerable guide catheter (sgc)and difficulty removing the sgc at the groin which has potential to cause or contribute to injury. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was deployed and the mr was reduced to >1. There was still a small jet; therefore, the decision was made to treat it with an additional clip. The second clip delivery system (cds) was advanced without issue; however, while steering to the valve with the m-knob, the device went upwards. The cds was retracted but became caught on the steerable guiding catheter (sgc) soft tip. Both devices were pulled to groin, and resistance was felt. A contrast injection was performed to see what the resistance was. It was found that the access site had been made through an internal vein instead of the femoral vein. The clip was advanced forward, and then successfully retracted in the sgc. The devices were then removed without resistance. Outside the anatomy, the devices were inspected and it was found that the alignment marker appeared to be 20 percent off. The mr was reduced to <1 with the one clip implanted. No further clips were attempted. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Manufacturer Narrative
(b)(4). The complaint device was returned for evaluation. The reported difficulty removing the device could not be tested during returned device analysis, but a tear in the soft tip material was identified. The investigation concluded that the reported user experience of difficult to remove the sgc from the anatomy was related to user error, as the access site was made at the internal vein instead of the femoral vein, while the soft tip tear was related to user technique/procedural conditions. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents reported from this lot. It should be noted that the mitraclip instructions for use instructs to insert the guide-dilator assembly over the stationary guide wire into the femoral vein. In this case, it was reported that the device access site was the internal vein instead of the femoral vein. 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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Manufacturer (Section D)
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
MDR Report Key5429526
MDR Text Key38154234
Report Number2024168-2016-00777
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 02/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2016
Device Catalogue NumberSGC0101
Device Lot Number50311U216
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial