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

Model Number SGC0701

Device Problems Difficult or Delayed Positioning (1157); Failure to Advance (2524); Unintended Movement (3026)

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/14/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed to report unintended movement of the steerable guide catheter (sgc), pericardial effusion, cardiac tamponade, atrial perforation requiring surgical intervention and death.It was reported that this was a mitraclip procedure performed (b)(6) 2021 to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the atrial septum and resistance was encountered while advancing the sgc across the septum.Tenting was noted but was felt to be normal.As the physician continued to push and advance the sgc, the sgc jumped impacting the lateral left atrial wall causing pericardial bleeding and cardiac tamponade.The mitraclip procedure was aborted with no insertion or implantation of mitraclips and no reduction in mr.The patient underwent surgical intervention for pericardiocentesis and repair of atrial perforation.Despite intervention, following surgery the patient died on (b)(6) 2021.In the physician¿s opinion, the jumping of the sgc and subsequent impact to the atrial wall contributed to the patient¿s death.A clinically significant delay was reported.No additional information was provided.

Event Description

Subsequent to the initially filed report, additional information was received.It was reported that the patient had challenging anatomy, specifically a floppy septum, that caused the resistance when advancing the steerable guide catheter (sgc) across the septum.The septum kept on pushing back on the sgc.The physician advanced the sgc against the resistance, and once the sgc was through the septum, there was a release of the tension from the septum, and the sgc went straight to and impacted the left atrial wall.

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.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the unintended movement of the steerable guide catheter (sgc).The reported pericardial effusion, cardiac tamponade and subsequent death appear to be due to the reported perforation and the perforation appears to be relate to the unintended movement of the sgc.Pericardial effusion, cardiac tamponade, perforation and death are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported delay to treatment/therapy and surgical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.H6: medical device problem code 2524 was removed.

• 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: 13122026
• MDR Text Key: 283077392
• Report Number: 2024168-2021-12290
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10816R121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White