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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 Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
This report is filed due to a soft tip tear in the steerable guide catheter. The steerable guide catheter (sgc) was used during a mitraclip procedure with no reported complaint against this device. Reportedly the sgc soft tip was not torn. Subsequently, the sgc was returned to abbott vascular. Initial analysis of the returned sgc, done on (b)(6) 2018, noted that the soft tip of the sgc was torn. All soft tip material seemed to be present. There was no reported adverse patient effect due to the soft tip tear. No additional information was provided regarding this sgc issue.
 
Manufacturer Narrative
(b)(4). Evaluation summary: all available information was investigated and the steerable guide catheter (sgc) was noted to have a soft tip tear. The observed torn soft tip was a result of the clip getting caught on the guide tip; therefore, attributed to procedural conditions. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incident reported from this lot. 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 Key7511518
MDR Text Key108246516
Report Number2024168-2018-03546
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 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/06/2018
Device Catalogue NumberSGC0302
Device Lot Number71205U214
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/30/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/14/2018 Patient Sequence Number: 1
Treatment
MITRACLIP CLIP DELIVERY SYSTEM
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