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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 Unstable (1667); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The steerable guide catheter was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This report is filed for the unstable cap on the dilator which has potential to cause or contribute to patient injury. It was reported that during device preparation, the cap of the hemostatic valve on the dilator was unable to be tightened. The device was used anyway because it was used in the tricuspid valve on the right side where pressure is low. No blood came out the proximal end of the dilator. There were no other issues encountered. The dilator was successfully removed after the steerable guide catheter was advanced to the right atrium. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned and analyzed. The reported unstable dilator cap was not confirmed as the cap was able to be tightened and functioned as intended. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents reported from this lot. The mitraclip system instructions for use (ifu) states do not use the device if damage is detected. Use of damaged product may result in air embolism, vascular and/or cardiac injury. The ifu also states that the dilator is used for introduction of the steerable guide catheter into the femoral vein and left atrium. All available information was investigated and a definitive cause for the reported unstable dilator cap in this incident could not be determined. The returned device analysis confirmed that the cap functioned as expected once it was pressed back onto the rhv. Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture 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 Key5803642
MDR Text Key49906173
Report Number2024168-2016-04706
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 Received07/19/2016
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 Number60224U148
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2016
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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