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); Arrhythmia (1721); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

The device is retained by hospital and not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system is filed under a separate medwatch report number.

Event Description

This is filed to report the air embolism.It was reported this was a mitraclip procedure performed to treat grade 4+ functional mitral regurgitation.After the mitraclip delivery system (cds) was introduced, the steerable guide catheter (sgc) failed to hold column, and air was introduced into the left atrium.The sgc was lowered to the patient¿s side below the heart and then put back on the stabilizer.More air was visualized, and the patients pressure dropped.Electrocardiogram noted st elevation, and the right ventricle was hypokinetic.The patient was shocked one time.A new sgc was prepped and the same cds was re-prepped; however, when re-prepping and changing the stopcock the flush port of the clip introducer separated into pieces.Therefore, the cds was no longer used.A new cds was used, one clip was implanted, reducing mr to <1.The patient is doing well with no neurological damage.There was no clinically significant delay during the procedure.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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and without the device to analyze, a cause of the reported leak/ splash (loss of fluid column during procedure) could not be determined.The reported air embolism was due to the reported leak.The reported hypotension appears to be a secondary effect of air embolism.The reported ekg/ecg changes and arrhythmia (hypokinesis of left ventricle) also appear to be related to the air embolism.The reported patient effects of embolism, hypotension and cardiac arrhythmias as listed in the mitraclip system instructions for use are 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.H6, codes 1838 and 1816 removed.

• 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: 14672885
• MDR Text Key: 293848408
• Report Number: 2024168-2022-06306
• 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,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 11216R134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: MITRACLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female