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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  Injury  

Event Description

This will be filed to report a loss of fluid column.It was reported that a patient presented with grade 3 functional mitral regurgitation (mr) and a dilated atrium.During a mitraclip procedure, the steerable guide catheter (sgc) was positioned in the left atrium.Inserting the clip introducer into hemostasis valve of the sgc was presented with difficulty.The clip introducer could not be inserted, and a loss of column was observed from the hemostasis valve.Air was also observed in the sgc, which required additional aspiration outside of standard procedure.The sgc was removed and replaced.The clip introducer was able to be inserted and the procedure was successful.The mr was reduced to grade <1.There were no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported leak / splash (loss of fluid column during procedure) and difficult to insert (cds into sgc) was confirmed via returned device analysis.Additionally, the sgc hemostasis valve was observed to be torn.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.Based on available information, the reported leak/splash (loss of fluid column during procedure) appears to be due to the torn sgc hemostasis valve.The reported difficult to insert (cds into sgc) was also due to the torn sgc hemostasis valve as the clip introducer¿s insertion pathway would likely be obstructed.A cause of the observed torn hemostasis valve could not be determined.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.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• 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: 17128509
• MDR Text Key: 317210597
• Report Number: 2135147-2023-02576
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/17/2023

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: 02/12/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30213R1083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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; MITRACLIP
• Patient Outcome(s): Required Intervention