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

Model Number SGC0701

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 10/21/2021

Event Type  Injury  

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 other incidents reported from this lot.Based on available information, a cause of the reported difficult positioning and air embolism were due to procedural conditions.A cause of the reported ecg changes and hypotension could not be determined.The reported patient effects of hypotension, ekg/ecg changes (cardiac arrhythmias) and air embolism are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report air embolism, medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The steerable guide catheter (sgc) was inserted into the patient when the st changed and the blood pressure decreased.Air was observed in the apex of the left ventricle.It was noted that there was some resistance when the sgc crossed the septum and while the sgc was at the septum, it is possible that traction on tissue caused suction and some air to form.The patient was placed in the trendelenburg position to remove the air and the patient's condition slowly improved.Therefore, the procedure continued and the sgc was advanced to the mitral valve.Then the clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed.However the final mean pressure gradient was 8mmhg.Despite the increase in gradient, the physician was satisfied with the outcome.The patient was discharged.One clip was deployed, reducing mr to 1-2.There were no adverse patient effects and 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: 12787188
• MDR Text Key: 280584410
• Report Number: 2024168-2021-10198
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10322R325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 78 KG