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Catalog Number SGC01ST
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Physical Property Issue (3008); Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 03/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The steerable guide catheter is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Event Description
This report is filed for the tear noted on the soft tip of the steerable guide catheter observed during device preparation. 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 that when the steerable guiding catheter (sgc) was removed from the sterile package, the +/- knob was not in neutral position as expected. Functional testing was performed per the instructions for use (ifu). The knob was turned 45 degrees in plus direction, but the tip of the sgc was not moving and a click was heard. Additionally, when flushing during device preparation, a tear was observed in the soft tip of the sgc. The device was not used in the anatomy and there was no patient involvement. Another sgc was used in the intended procedure. There was no clinically significant delay to the procedure. No additional information was provided.
Manufacturer Narrative
(b)(4). Evaluation summary: (b)(4). The complaint device was returned for evaluation. The reported torn soft tip was not confirmed via returned device analysis. The reported irregular appearance (+/- knob was not in neutral position when removed from the sterile package) could not be replicated in a testing environment as it was related to procedure conditions (user observation). The reported noise could not be replicated in the testing environment as the event was a symptom of the cable break. The reported mechanical issue of steerable guiding catheter unable to curve guide was confirmed. The investigation concluded that the reported noise and mechanical issue was due to the observed cable break; however, a definitive cause for the cable break could not be definitively determined. The reported torn soft tip was user observation, related to 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 similar incidents reported from this lot. 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 Key5539060
MDR Text Key41777899
Report Number2024168-2016-02084
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2016
Device Catalogue NumberSGC01ST
Device Lot Number50407U117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial