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Catalog Number SGC0301
Device Problem Difficult To Position (1467)
Patient Problem Atrial Perforation (2511)
Event Date 07/10/2017
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 identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. The reported patient effect of atrial septal defect, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. The reported difficulty positioning the sgc appears to be related to procedural conditions, as the sgc tip diving lateral was likely a secondary effect to the sleeve steering issue experienced with the cds. The reported patient effect of the atrial septal defect appears to be due to procedural conditions and the sgc inserted through the septum to access the left atrium. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device. The clip delivery system referenced is filed under a separate medwatch report number.
Event Description
This is being filed to report the tear on the septum. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+. The steerable guide catheter (sgc) was advanced without issue. The clip delivery system (cds) was advanced to the left atrium. While steering down with the m-knob, it was noted that the cds was steering lateral and the sgc was diving lateral. An attempt was made to open the clip to orient to the valve; however, the clip did not open and there appeared to be a lot of tension on the device. When the lock lever was retracted further, the clip jumped open and the cds would deflect medial. Troubleshooting was performed, and the arm positioner was turned, but the clip opened while locked. As the position of the cds was not satisfactory to the valve, grasping could not be attempted. The cds was removed and replaced. A new cds was used without issue. One clip was implanted, reducing the mr to 1. After removal of the sgc, it was noted that there was a tear on the septum, with a left to right shunt. As the patient was hemodynamically stable, no treatment was performed for the tear and the patient was confirmed to be clinically stable, with a good outcome post procedure. No additional information was provided.
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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 Key6745916
MDR Text Key81113793
Report Number2024168-2017-06231
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
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/04/2018
Device Catalogue NumberSGC0301
Device Lot Number70404U149
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 Received07/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
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: 07/26/2017 Patient Sequence Number: 1