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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 SGC0101
Device Problems Improper or Incorrect Procedure or Method (2017); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Failure to follow steps/instructions. The device was not keyed properly during use. The customer reported the steerable guiding catheter was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system referenced is filed under a separate medwatch report number.
 
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 that this was a mitraclip procedure to treat degenerative mitral regurgitation, grade 4+. The first clip was successfully implanted. While inserting a 2nd clip delivery system (cds) into the steerable guide catheter (sgc), the device was "miskeyed" - the cds blue line markers were not aligned to the sgc as directed in the instruction for use (ifu). The operator was unaware of the miskeying at the time. This same cds was advanced into the left atrium. During delivery catheter positioning and steering, the device was not responding as expected. It was then noted that the cds had been miskeyed. During cds retraction back into the sgc, resistance occurred. The clip had become fixed to the soft tip of the sgc and was unable to be retracted into the sgc. The cds and sgc were retracted into the inferior vena cava. Minus was applied to the sgc and the cds retracted into the sgc. Both were removed from the patient anatomy. During the removal process, the sgc soft tip had become damaged. A new sgc was placed and a 3rd cds system was used successfully implanting the clip. The mr had been reduced to grade 2. There were no adverse patient effects and there was no clinically significant delay. There was no additional information 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 similar incidents reported from this lot. All available information was investigated and the reported soft tip tear appears to be related to user technique. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial medwatch report filed, the additional information was received: during mitraclip removal, the clip arms were fully closed and the steerable guide catheter (sgc) was initially straightened per instructions for use (ifu). The clip delivery system (cds) was retracted into the guide quickly. The clip became stuck on the guide tip. The sgc and cds were retracted into the inferior vena cava in order to free the clip from the guide. Once the clip was freed, troubleshooting measures were performed and the cds with the mitraclip were retracted into the guide catheter and removed from the patient anatomy.
 
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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 Key5954844
MDR Text Key55149546
Report Number2024168-2016-06140
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue NumberSGC0101
Device Lot Number60517U136
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 Received10/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/15/2016 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP1 CLIP DELIVERY SYSTEM
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