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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Atrial Perforation (2511)
Event Date 02/18/2020
Event Type  Injury  
Manufacturer Narrative
The reported device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities. Additionally, a review of the complaint history identified no similar incidents reported from this lot. The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedure. All available information was investigated and the cause for reported tear on the steerable guide catheter (sgc) soft tip could not be determined. Perforation appears to be related to procedural circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional mitraclip device referenced is being filed under a separate medwatch report.
 
Event Description
This is filed to report soft tip damage and atrial perforation. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3. An xtr clip delivery system (cds) (91113u102) was advanced and grasping was successfully performed, reducing mr. During deployment of the clip, the gripper line was pulled, but after retracting roughly 1. 3m, the gripper line became stuck. In an attempt to remove the gripper line, the physician decided to remove the cds. However, after removal of the cds, the gripper line was still unable to be removed. Therefore, the physician decided to remove the steerable guide catheter (sgc) (91022u160) and insert a multipurpose catheter to try and remove the gripper line. It was noted that upon removal of the sgc, a slight slit was visible on the soft tip. When attempting to remove the gripper line, addition force was applied, which caused mr to increase. The gripper line was unable to removed, so to reduce mr, an additional clip was implanted while using a separate sgc. The gripper line was left in the patient and a closure the device was used to close the atrial septal defect. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9818642
MDR Text Key184445750
Report Number2024168-2020-02264
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2020
Device Catalogue NumberSGC0302
Device Lot Number91022U160
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 Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2019
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: 03/11/2020 Patient Sequence Number: 1
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