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

Model Number SGC0701

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994); Perforation of Vessels (2135)

Event Date 04/10/2023

Event Type  Injury  

Event Description

This is filed to report vessel perforation and bleeding.It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 3-4.While advancing the steerable guide catheter (sgc) resistance was felt.It was noted additional force was applied with advancing the sgc.At this point, it was observed the guidewire was bent.The patient's blood pressure then started to drop.The sgc was then removed and imaging showed a laceration of the vein, which had caused a considerable retroperitoneal bleed.A balloon device was used to tamponade and stop the bleeding.The patient became stable, and the case was aborted.The mr remained at 3-4.The following day, the patient experiencing abdominal pain due to the reabsorption of blood.No additional information was provided.

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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on all available information and without the device to analyze, the reported difficult to advance associated with the difficulty to advance sgc-dilator assembly was due to procedural conditions (kink on the guide wire).The cause of the reported instructions for use (ifu) deviation was due to user technique; as it was decided to push the sgc-dilator assembly when resistance was noted.It should be noted that the mitraclip g4 clip delivery system instructions for use warns ¿do not use excessive force to advance or manipulate the guide-dilator assembly.If resistance is encountered, use echocardiography and / or fluoroscopy to assess before proceeding.Use of excessive force may result in arrhythmias, vascular and / or cardiac injury, including creation of a clinically significant atrial septal defect¿.It appears the reported perforation (laceration of the vein) appears to be a cascading effect of the reported ifu deviation.The reported hemorrhage, hypotension & pain are cascading effects of the reported laceration of the vein.Additionally, the reported perforation, hemorrhage, hypotension & pain, are listed in instructions for use (ifu) and are known possible complications associated with mitraclip procedures.The reported medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.H6: device code 2017 - failure to follow steps / instructions.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• 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: 16872476
• MDR Text Key: 314592836
• Report Number: 2135147-2023-01953
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20907R1039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male