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

Catalog Number SGC0702

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter leak.It was reported the mitraclip procedure was performed to treat grade 3 degenerative mitral regurgitation (mr).When the steerable guide catheter (sgc) was inserted into the left atrium, air bubbles were observed in the aorta.The air bubbles were successfully aspirated.Shortly after air bubbles were also discovered in the left atrial appendage which were also aspirated.Again, shortly after, air bubbles appeared in the left atrium, requiring aspiration.The decision was made to remove and replace the sgc.An air leak and broken valve is suspected; however, no visible damage was observed.No more air entered the patient with the new sgc.The procedure was finished successfully.One clip was implanted, reducing mr to 1.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.All available information was investigated, and the reported leak/splash and broken hemostasis valve were not confirmed via returned device analysis.The discrepancy between what was reported (leak) and what was observed (no leaks) may have been due to the user technique versus the returned product analysis.Additionally, the discrepancy between what was reported suspected broken (damaged) valve, and what was observed (no damage to the valve) was due to the user¿s perception for the cause of the leak and was not confirmed at the account 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 complaints reported from this lot.The reported patient effect of air embolism is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.All available information was investigated and a cause for the reported leak in this complaint could not be determined.The reported broken hemostasis valve was the user¿s perception for the cause of the leak.Air embolism was associated with the procedural circumstances of the leak at the account.The unexpected medical intervention was a result of case-specific circumstances.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: 12756214
• MDR Text Key: 283832936
• Report Number: 2024168-2021-10009
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/14/2021

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: 06/28/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10629R422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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
• Patient Outcome(s): Required Intervention