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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip devices are filed under separate medwatch report numbers.

Event Description

This is being filed to report during the procedure, cardiac arrest occurred possibly due to air embolism from possibly the steerable guide catheter.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.During preparation, the clip delivery system (cds) (cds0701-xtw, 10910r428) had bubbles in the delivery catheter handle.Attempts to eliminate the air bubbles let to more bubbles.Therefore, the cds was not used.A second cds (cds0701-xtw, 10910r426) was prepped successfully and advanced to the mitral valve.When positioning the clip, the patient blood pressure dropped, and went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed.The patient was checked for a pericardial effusion, but there was none seen.The sgc and cds were flushed, and all valves were cleared.There were no issues noted with the devices.Medication and extra oxygen were given to the patient.The patient was stabilized, and the procedure continued.The patient¿s blood pressure dropped again and heart rate.The patient was stabilized again, but it was decided to end the procedure as it was suspected the patient had an air embolism but was not confirmed.Outside the patient anatomy, the cds was inspected and there appeared to be air bubbles in the cds shaft.It was then thought that the steerable guide catheter (sgc0701, 10915r207) might have had a leak and not noted.The patient was stable after the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak was not confirmed via returned device 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 complaints reported from this lot.All available information was investigated and a cause for the reported leak in this complaint could not be determined.The reported air embolism, hypotension and cardiac arrest appeared to be related to the procedural conditions associated with the leak.Air embolism, hypotension and cardiac arrest are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The unexpected medical interventions and medication were 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: 13832229
• MDR Text Key: 287800906
• Report Number: 2024168-2022-02900
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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: 09/15/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10915R207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• 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
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization