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

Catalog Number SGC0705

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Air Embolism (1697)

Event Date 01/12/2021

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 the air embolism.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr), with an mr grade of 4.When inserting the steerable guide catheter (sgc), into the left atrium, resistance was felt with the anatomy.The sgc was removed and a balloon was used to dilate the septum.The sgc was reinserted without further resistance; however, air was observed in the left atrium, requiring aspiration.One clip was implanted, reducing mr to 1.The procedural delay from the air embolism resulted in prolonged anesthesia.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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Air embolism is listed in the instructions for use as known possible complication associated with mitraclip procedures.The investigation was unable to determine a cause for the resistance during insertion and air embolism.The reported additional therapy/non-surgical treatment and delayed additional therapy/non-surgical treatment were results 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
• MDR Report Key: 11270316
• MDR Text Key: 230007901
• Report Number: 2024168-2021-00819
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 01017U119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 47