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Catalog Number SGC01ST
Device Problems Difficult To Position (1467); Difficult to Remove (1528); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The patient was stable post procedure. No clips were implanted. The mr remained a grade of 4. There was no clinically significant delay during the procedure. No additional treatment has been planned. No additional information was provided. The steerable guide catheter was received. Investigation is not complete. A follow up report will be submitted with all relevant information.
Event Description
This report is filed for the tear noted on the soft tip of the steerable guide catheter. A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy. It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The transseptal puncture was guided through echocardiogram and a good position of the transseptal needle was observed. During insertion of the steerable guide catheter (sgc) in the left atrium it was observed that the sgc tip was in an irregular position; it went from the posterior to anterior direction. Echographic visualization was difficult due to the abnormal position. The clip delivery system (cds) was inserted. In attempts to advance the cds to the mitral valve and compensate for the irregular position of the sgc, the m knob was turned. After multiple unsuccessful positioning attempts, the decision was made to make another transseptal puncture to aide in the deflection of the cds to the mitral valve. While retracting the clip into the tip of the sgc, difficulty was noted. Several attempts were made and the clip was retracted into the sgc and both devices were removed. After removal of the sgc, a tear was noted on the sgc tip. During insertion of the guide wire for the second transseptal puncture, a small pericardial effusion was confirmed through echocardiogram. Heparin was reversed and the procedure was aborted. Minutes after, it was confirmed the pericardial effusion had stopped. It is the physician's opinion that the effusion was not related to the sgc or cds.
Manufacturer Narrative
(b)(4). Evaluation summary: all available information was investigated and the reported steerable guide catheter (sgc) torn soft tip was confirmed. The reported sgc steering issue was not confirmed, as the returned sgc steered with no issues and had no abnormal steering effects on a proxy clip delivery system (cds). A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no other incidents reported from this lot. The investigation determined that the reported soft tip tear and sgc steering issues appear to be a result of the abnormal transseptal puncture that resulted from poor transesophageal echocardiography. Furthermore, the reported soft tip tear is a result of the clip becoming caught on guide, which is likely related to the abnormal positioning of the sgc. The returned device analysis confirmed tears in the soft tip which is indicative of an interaction between the clip and guide tip during retraction; however, the analysis was unable to replicate the difficulty retracting a proxy cds into the returned sgc. 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
Subsequent to the initial medwatch report filed, additional information received: the transseptal puncture was guided through transesophageal echocardiography. It is the physician's opinion that the pericardial effusion probably resulted from a bad transseptal puncture, due to imaging challenges. There was no steering issue due to the clip delivery system. The cds m-knob was used to correct for the steerable guide catheter irregular position.
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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 Key5975046
MDR Text Key55875075
Report Number2024168-2016-06352
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
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,Followup
Report Date 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue NumberSGC01ST
Device Lot Number60510U135
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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: 09/23/2016 Patient Sequence Number: 1