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Catalog Number SGC0302
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number (b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The clip delivery system (cds) referenced is filed under a separate medwatch report number.
Event Description
This is being filed to report the tear in the sgc soft tip. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The location of the transseptal puncture was too anterior and after steering down to the mitral valve, the ntr clip delivery system (cds) was already at the height of the mitral valve and in an "aortic hugging" position. Due to the suboptimal transseptal puncture, grasping was difficult and both mitral valve leaflets were unable to be grasped. The ntr cds was removed and an xtr cds was prepared and advanced into the steerable guide catheter (sgc). The xtr clip was unable to achieve a satisfactory grasp of both leaflets therefore the clip was inverted in the left ventricle and moved to the left atrium (la). The clip was closed and an attempt was made to retract the cds into the sgc however one clip arm was going over the soft tip of the sgc therefore the cds could not be retracted. The cds was advanced and the clip closed again however when retracting, the same issue occurred. The clip stuck on the tip of the sgc and detached from the delivery catheter (dc). Under fluoroscopy both l-lock tabs could be seen detached from the clip and the mandrel was not visible. The cli arms appeared to open about 40-50 degrees. The sgc with the attached clip was pulled through the septum causing a significant hole in the septum with a shunt from left to right. The patient remained hemodynamically stable. After pulling the clip through the septum it detached from the tip of the sgc but was still secured by the lock and gripper lines. The sgc and clip were able to be pulled back to the groin where it became stuck requiring removal by a surgeon. After inspection of the sgc it was noted the soft tip was torn but not missing material. The patient remained in stable condition in the hospital is planning a second procedure after which the atrial septal defect is going to be closed using an occluder device. A second procedure was performed on (b)(6) 2019. A cds was advanced to the mitral valve however it was noted the gripper lever could be pulled forward and back although the lever was locked. The cds was able to be used and the clip deployed. Another clip was implanted, reducing the mr to 1-2. No additional information was provided.
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Type of DeviceVALVE REPAIR
Manufacturer (Section D)
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
MDR Report Key8950005
MDR Text Key170088196
Report Number2024168-2019-11349
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/09/2020
Device Catalogue NumberSGC0302
Device Lot Number90610U106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial