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 01/11/2022

Event Type  Injury  

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 the reported complaint.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and without the device to analyze, a cause for the reported leak could not be determined.The unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report leak and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the mitral valve, and one clip was deployed.Then after the clip delivery system (cds) was removed, the sgc failed to hold column.Aspirations were performed and air did not enter the patient.The procedure ended at this point.One clip was implanted, reducing mr to 1.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 13358616
• MDR Text Key: 284463603
• Report Number: 2024168-2022-00854
• 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
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10915R131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG