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

Model Number SGC0701

Device Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problems Air Embolism (1697); Tachycardia (2095)

Event Date 11/02/2022

Event Type  Injury  

Event Description

This is filed to report a leak, slit on the guide, tachycardia and air embolism requiring intervention.It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr).During the procedure, the steerable guide catheter (sgc) was inserted over the guide wire and up to the septum.There was difficulty crossing the septum with the sgc.The dilator was advanced to dilate the septum further and the sgc was able to cross.When removing the dilator and aspirating, air was drawn into the chamber on the sgc.There was no contact with tissue in the heart.Aspiration was continued while pulling the dilator back and continued to get blood back.The 3 way stopcock was replaced and the extension tubing, with the assumption both were possibly the source of air ingress.Aspiration was attempted again, but air still pulled into the chamber.At this point it was decided to replace the sgc.Once the sgc was removed it was noted that the hemostasis valve on the back end of the sgc had a slit in it.The patient briefly went into ventricular tachycardia (vt) due to an air embolism and cardioversion was performed and the patient returned back to normal rhythm.The procedure was completed with 2 implanted mitraclips and a mr grade reduction to 1-2.There was no adverse patient sequelae or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 did not indicate a lot-specific quality issue.Based on available information and without the device to analyze, the cause of the reported leak/splash (air ingress), slit (hemostasis valve), and difficult or delayed positioning (anatomy) were unable to be determined.The reported air embolism was a cascading event of the reported leak/splash (air ingress).The reported tachycardia was due to the air embolism.The reported patient effect of embolism, as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15845040
• MDR Text Key: 304122513
• Report Number: 2135147-2022-02163
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 06/08/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20609R107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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: 88 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White