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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 Leak/Splash (1354); Unstable (1667); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). Failure to follow steps/instructions - used after leak detected. 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 is filed to report that during preparation, the steerable guiding catheter (sgc) flush port was leaking. Leaks have the potential to cause or contribute to patient injury. It was reported that during preparation of the sgc, leaking was observed and it was noted that the 3-way taps to the sgc flush port were not able to be sealed. Multiple 3-way taps were tried, all with the same effect. Tape was used to seal the 3-way taps and the device was used successfully to treat functional mitral regurgitation (mr) with a grade of 4. One clip was implanted, reducing 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). Evaluation summary: the device was returned and investigated. The reported issues of loose/intermittent connection resulting in a leak were unable to be confirmed as proxy stopcocks were able to be securely attached. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents reported from this lot. Reportedly, tape was used to seal a stopcock to the steerable guide catheter (sgc) flush port. The mitraclip system instructions for use warns: do not use if damage is detected. Use of damaged product may result in air embolism, vascular and/or cardiac injury. All available information was investigated and the reported loose/intermittent connection resulting in a leak is possibly related to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively determined. The returned device analysis confirmed that the sgc flush port functioned as expected. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design 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 Key5798621
MDR Text Key49946334
Report Number2024168-2016-04616
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAS
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 10/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberSGC01ST
Device Lot Number60222U110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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