MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0705

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Thrombosis (2100)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the blood clot requiring aspiration.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced with resistance noted when passing through the septum.After removing the dilator and guide wire, a bright object thought to be a blood clot was noted on echo on the tip of the sgc.Aspiration was performed however the blood clot could not be removed.The decision was made to continue the procedure.The clip delivery system (cds) advanced to the left atrium (la) and the grippers tested.The gripper on the anterior side lowered without issue however the gripper on the posterior side would not lower.The lock lever was changed to the locked position and both grippers were able to lower; however the gripper lever latch came off.The physician continued with use of the device and the clip implanted without further issues.After removal of the cds, the sgc tip was confirmed on echo and the blood clot was gone.The sgc was removed and the procedure completed with the mr reduced to 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot which could have contributed to the reported events.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.Based on the information reviewed, the reported difficult or delayed positioning (anatomy) was due to procedural conditions as a blood clot was found on the tip of the steerable guide catheter (sgc)which made it difficult to advance it through the septum.A cause for the reported thrombosis could not be determined.The reported patient effect of thrombosis, as listed in the mitraclip nt system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case specific circumstances as aspiration as performed to treat the reported thrombosis.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10986748
• MDR Text Key: 220909520
• Report Number: 2024168-2020-10388
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 00821U340
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 55