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

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

The additional devices are filed under separate medwatch report numbers.The device will not be returned for evaluation; the device was reportedly discarded.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 air embolism.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) (lot 11011r181) was advanced and placed on the lateral side of p2.After locking and closing, the clip failed to establish final arm angle (efaa).The clip would open and close with each heart-beat therefore the decision was made to not implant the clip and the cds was removed.The second cds (lot 11014r415) was advanced and deployed at the intended location without issue.A third cds (lot 10917r189) was advanced into the steerable guide catheter (sgc) when it was noticed that the tip of the sgc has crossed into the right atrium.The physician decided to remove the cds from the sgc with the intent of using a wire and dilator to recross the septum and continue with the procedure.As the clip was being removed, the physician aspirated air into the system.It is believed that the tip of the sgc was in contact with the septum which caused the introduction of air during aspiration of the sgc.No damage was noted to the septum.At that moment, the physician decided to rapidly remove the clip and pulled on the clip introducer after erroneously believing that the clip was fully retracted into the clip introducer.At that moment, the physician pulled on the sleeve to forcefully remove the clip.The clip however got caught in the hemostatic valve of the sgc.Because air was being introduced, the entire system (sgc and cds) was immediately removed from the patient.The physician chose to abort the procedure at this moment with the mr reduced to 3.No treatment was performed for the air in the patient as there were no immediate negative repercussions to the patient.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported air embolism appears to be due to procedural circumstances.The reported patient effect of air embolism as listed in the mitraclip instructions for use (ifu), is known possible complications associated with mitraclip procedures.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
• 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 Key: 13568728
• MDR Text Key: 287797565
• Report Number: 2024168-2022-01749
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10929R116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male