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

Model Number SGC0701

Device Problems Leak/Splash (1354); Difficult to Advance (2920)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)

Event Date 01/25/2022

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 indicate a lot-specific product issue.All information was investigated and a cause for the difficult advancement and steerable guide catheter (sgc) leak cannot be determined.The reported air embolism resulting in hypotension appears to be related to the procedural conditions associated with the sgc leak.Air embolism and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.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.

Event Description

This is filed to report a leak, air embolism, medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.It was noted a previous implanted pacemaker, calcium on posterior annulus, and a cleft.The clip delivery system (cds) was to be advanced into the steerable guide catheter (sgc); however, during alignment, resistance felt when the cds was advancing through the sgc valve.Force was applied and the cds was able to be advanced into the sgc.Later in the procedure, the clip briefly interacted with the chords.The clip was freed with standard troubleshooting and the procedure continued.But then during clip deployment, the right atrium (ra) and right ventricle (rv) began filling with fluid.The patient's blood pressure dropped.An epi drip was begun, and the patient recovered from a possible air bubble in the right coronary artery.The patient's blood pressure returned to normal and the ra/rv was free from fluid.The clip was deployed without issue.One clip was implanted, reducing mr to 1.There was reported no clinically significant delay in the procedure.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: 13552641
• MDR Text Key: 285818794
• Report Number: 2024168-2022-01671
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10915R517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 83 KG