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

Model Number SGC0701

Device Problem Difficult to Advance (2920)

Patient Problem Perforation of Vessels (2135)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated, and the reported failure to difficult to advance the sgc appears to be related to patient conditions (tortuous iliac vein).Additionally, based on the information reviewed, the reported perforation of vessels is related to procedural conditions associated with difficulty advancing the sgc.Vessel perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Surgical 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 perforation.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4 and a tortuous iliac vein.A steerable guide catheter (sgc) was inserted into the iliac vein, resistance was noted while advancing and a pop was heard.The pop was suspected to be a perforation of the vein.The procedure was continued, and two clips were successfully implanted.When the sgc was removed, a small hole in the iliac vein was observed and the hole was repaired by a vascular surgeon.Mr was reduced to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.

• 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: 17204022
• MDR Text Key: 317907165
• Report Number: 2135147-2023-02779
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 30111R1043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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
• Patient Outcome(s): Required Intervention