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

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.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The reported torn soft tip was confirmed.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.All available information was investigated, and the reported torn soft tip in this incident appears to be related to the procedural circumstances of the clip becoming caught on the guide soft tip during removal.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8950005
• MDR Text Key: 170088196
• Report Number: 2024168-2019-11349
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90610U106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM