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

Model Number SGC0701

Device Problem Leak/Splash (1354)

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

Event Date 11/18/2021

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 two additional mitraclip devices referenced are filed under separate medwatch report numbers.

Event Description

This is filed to report leak and medical intervention.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.It was noted thickened and restricted leaflets.The first steerable guide catheter (sgc 10514r223) was advanced to the mitral valve; however, the guide lost column and air entered the sgc.One aspiration was performed to remove the air from the column and the sgc was safely removed.Air did not enter the patient, a second sgc (10625r222) was being prepared; however, when the dilator was advancing into the sgc, the guide would not hold column.The sgc was not used in the patient.The procedure continued with a third sgc.The sgc was advanced to the mitral valve, and one clip was deployed without issue.The clip then became detached from detached from the anterior leaflet, but remained attached to the posterior leaflet (single leaflet device attachment/slda).Therefore, a second clip was deployed to stabilize the slda and further reduce mr.Two clips were implanted, reducing mr to 1.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the returned device analysis confirmed the reported loss of fluid column and it appears to be due to an observed tear in the silicone valve of the hemostasis valve.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.The investigation determined the reported loss of fluid column to be related to the identified torn silicone valve.However, a cause for the observed torn silicone valve could not be determined.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

Event Description

N/a.

• 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: 12952804
• MDR Text Key: 281855662
• Report Number: 2024168-2021-11176
• 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: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10514R223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 100 KG