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

Catalog Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Stroke/CVA (1770)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.The udi is unknown due to the part/lot number was not provided.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report clip open, leak, air embolism and medical intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade of 4+.The steerable guide catheter (sgc) was advanced to the mitral valve without issue.Then the first clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed, reducing mr.However, the clip opened passed 60 degrees and mr increased.Although the clip is stable on both leaflets, a second clip was deployed to stabilize the opened clip a bit more.The physician stated that at some point during the procedure, one of the saline bags emptied and air bubbles entered the atrium resulting in a clinically significant delay.The saline bag was changed and aspirations were performed to remove the air.It was noted there was no reported issue connecting the sgc to the saline bag.The patient is stable.Two clips were implanted, reducing mr to 2-3.Then as of (b)(6) 2021, the patient is not doing so well.The physician stated it is uncertain if the air embolism is the reason for the patient's condition.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following additional information was received: the same day, after the procedure, the patient was still intubated and non-responsive.The physician is uncertain if the patient suffered a stroke.The patient will remain hospitalized.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.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.All available information was investigated and a cause for the reported leak in this incident could not be determined.It is possible that user technique and procedural conditions influenced the leak however this cannot be confirmed.The reported air embolism was due to the reported leak.The reported cardiovascular accident was likely a result of the reported air embolism.The reported delay to treatment/therapy, unexpected medical intervention and hospitalization were a result of case-specific circumstances, as aspiration was performed to remove air from the anatomy and patient was hospitalized respectively.Additionally, the reported patient effects of air embolism and cardiovascular accident are listed in the instructions for use (ifu) as 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: 12642695
• MDR Text Key: 276947312
• Report Number: 2024168-2021-09277
• Device Sequence Number: 1
• Product Code: DRA
• 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,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Catalogue Number: SGC0701
• Device Lot Number: 10311U129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization; Disability
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG