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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 SGC0302
Device Problems Kinked (1339); Failure to Advance (2524); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
This is filed to report the tear noted at the distal end of the steerable guide catheter. It was reported that during a mitraclip procedure, the steerable guide catheter (sgc) was advanced into the patient anatomy; however, the sgc was unable to advance through the inferior vena cava when crossing the pelvic ridge, due to the tortuosity of the vein. Fluoroscopy was used to navigate, but resistance was felt prior to the tip reaching the right atrium. The device was removed from the anatomy, and it was noted that distal end of the sgc was kinked and torn. The sgc was replaced and the procedure was completed with implantation of one clip. Mitral regurgitation was reduced from grade 4 to grade 1-2. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: all available information was investigated and the results of the returned device analysis confirmed the reported kinked steerable guide catheter (sgc) shaft; however, the reported sgc torn shaft was not confirmed. The reported failure to advance the device into the anatomy could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances). A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents reported from this lot. The reported failure to advance the sgc was related to patient morphology/anatomy; specifically, due to the tortuosity of the vein. Reported kink on the shaft was a cascading effect/maneuver related to failure to advance the scg. A definitive cause for the torn material (shaft) cannot be determined, it is possible that the account has mistaken the kink as a torn, however it could not be confirmed. 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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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
MDR Report Key7358712
MDR Text Key103282016
Report Number2024168-2018-02038
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2018
Device Catalogue NumberSGC0302
Device Lot Number70815U140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/21/2018 Patient Sequence Number: 1
Treatment
SHEATH: 8FRENCH
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