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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 SGC01ST
Device Problems Bent (1059); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer reported the steerable guide catheter was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report that during advancement of the steerable guiding catheter (sgc), the sgc became stuck. After removal, the sgc soft tip was damaged. Difficult to remove has the potential to cause or contribute to patient injury. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+. During insertion of the steerable guiding catheter (sgc), the wire kinked due to the narrow vessel. The sgc could not be advanced and became stuck due to resistance with the anatomy and the guide wire. Force was used to advance the sgc, and the tip of the sgc was stressed. After multiple attempts to advance, the sgc was removed for visual inspection. During removal, resistance was again noted. There was strong bending observed, and the tip of the sgc was bent. The device was replaced, and a new sgc was used to continue the procedure. Two clips were implanted, reducing the mr to <1. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). 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 mitraclip instructions for use- steerable guide insertion states the following warning: do not use excessive force to advance or manipulate the guide-dilator assembly. If resistance is encountered, use echocardiography and/or fluoroscopy to assess before proceeding. All available information was investigated and the reported failure to advance the steerable guiding catheter (sgc) appears to be related to challenging vessel anatomy. The reported bent sgc shaft, resulting in difficulties removing the device, appears to be a result of user error. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing 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 Key5795848
MDR Text Key49628056
Report Number2024168-2016-04593
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112239
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 08/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Catalogue NumberSGC01ST
Device Lot Number51020U215
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 Received07/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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