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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 04/15/2022

Event Type  Injury  

Event Description

This is being filed to report the leak resulting in air embolism requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the mitral valve without issue.The first clip delivery system (cds) was successfully inserted into the sgc, and the clip was deployed.The cds was removed fine.Then a second cds was advancing into the sgc; however loss of fluid column was observed.Aspirations were performed.The cds was removed and re-inserted, but half way through, loss of fluid column was observed again.The sgc was immediately dropped down below the patient's body; however air embolized to the left atrium (la).Aspirations were performed, and the guide was able to remove all the air/air embolism.The patient was stable and the procedure continued.The sgc was removed and a new sgc was advanced to complete the procedure.The same cds was re-inserted into the sgc without issue and the clip was deployed, reducing mr to 1.There was no clinically significant delay in the procedure and no patient sequela.No additional information was provided.

Manufacturer Narrative

The return device analysis did not confirm the reported leak.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, based on the similar complaint review, there is no indication of a lot-specific product quality issue.Based on available information and return device analysis, the cause of the reported leak could not be determined.Additionally, the reported air embolism is a cascading effect of the reported leak.The reported air embolism is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality 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: 14310552
• MDR Text Key: 290935282
• Report Number: 2024168-2022-04927
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 11201R249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2021
• 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): Required Intervention
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 64 KG