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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Leak/Splash (1354)

Patient Problems Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

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 filed to report leak, air embolism, bradycardia, and medical intervention.It was reported that this was mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that the dilator was inserted with difficulty during preparation.The steerable guide catheter (sgc) was advanced to the mitral valve; however, after removal of the dilator from the sgc, an air embolism was suspected.The st-elevation reduced contractility and reduced heart rate.Chest compression were performed.Additionally, inotropic agents and temporary pacing were applied.After 2-3 minutes, the patient recovered and the procedure continued without issues.Two clips were implanted, reducing mr to 2.The next day, the patient was still stable.There was no reported clinically significant delay in the procedure.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.Additionally, a review of the complaint history identified no similar other complaints from this lot.Based on available information and without a device to analyze, causes for the reported difficulty inserting the dilator and leak could not be determined.The reported air embolism appears to be a cascading event of the leak.The ecg changes and bradycardia appear to be cascading events of the air embolism.Additionally, air embolism, ecg changes, and bradycardia (cardiac arrhythmia) are listed in the instructions for use as known possible complications associated with mitraclip procedures.The unexpected medical intervention and medication were the results of case-specific circumstances.There is no indication of 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: 12934759
• MDR Text Key: 281753402
• Report Number: 2024168-2021-11096
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10212U332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG