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 08/25/2021

Event Type  Injury  

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 the reported leak in this incident appears to be due to user technique and procedural conditions.The reported air embolism was due to the reported leak.The unexpected medical intervention and medication required were a result of case-specific circumstances, as aspiration was performed to remove air from the anatomy and medication was administered.Additionally, the reported patient effect of air embolism is listed in the instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a leak and air embolism.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An nt clip was placed on the mitral valve, reducing mr to a grade of 1.However, while attempting to remove the devices, the physician pulled on the clip introducer (ci), causing a loss of fluid column and air to enter the device and anatomy.Which resulted in a clinically significant delay.The ci was put back to the original position and aspiration was performed.The air in the steerable guide catheter (sgc) was successfully remove, but the air in the anatomy remained.It was noted once the ci was corrected, the loss of fluid column no longer occurred.The air embolism had migrated and come to rest in the apex of the left ventricle (lv).Therefore, the physician decided to remove the mitraclip devices before attempting to treat the air embolism.For treatment, additional medication was administered, and the physician decided to shake the patient¿s chest in an attempt to break up the air embolism.This method was successful; therefore, no additional treatment was performed.It was noted the patient is in stable condition.No additional information was provided.

• 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: 12492609
• MDR Text Key: 272132859
• Report Number: 2024168-2021-08277
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

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: 03/14/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10312R120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR