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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 Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the displacement of the pacing lead. It was reported that this was a mitraclip procedure to treat grade 3-4 degenerative mitral regurgitation (mr). One mitraclip was successfully implanted reducing mr to grade 1-2. When the steerable guide catheter (sgc) was retracted into the right atrium according to the instructions for use, the sgc interacted with the right ventricular pacing lead and dislodged the lead. A temporary pacing lead was inserted before a new right ventricular pacing lead was implanted. No additional information was 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. Review of the complaint history identified no similar incidents reported from this lot. The reported device causing damage to another device (pacer lead) appears to be a combination of the patient morpholgy/pathology and user technique/procedural conditions. 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 Key7820591
MDR Text Key118389121
Report Number2024168-2018-06634
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 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2019
Device Catalogue NumberSGC0302
Device Lot Number80402U114
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/27/2018 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP
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