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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 05/24/2022

Event Type  Injury  

Event Description

This is filed to report the perforation of the arterial vessel and bleeding requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.The femoral vein was accessed without using ultrasonic assistance.The transseptal sheath and needle were advanced in the patient and the transseptal puncture was performed, a stiff wire was placed in the patient and the femoral access site was dilated using a 18f dilator.The steerable guide catheter (sgc) was inserted in the groin, however high tissue resistance was noted.The sgc was removed from the patient without difficulty and the femoral access site was temporarily closed by manual compression to avoid bleeding.The vessels were visualized by using contrast injection to find the spot of blood exit.The arterial vessel was punctured, and the physician performed the crossover technique to place a covered stent to close the injury of the arterial vessel.The procedure was aborted so the patient could recover from the stent treatment.The physician suspects the arterial vessel was inadvertently punctured when accessing the femoral vein at the beginning of the procedure.There were no reported device malfunctions related to the sgc, however it may have contributed to the injury during the insertion attempt.The clip delivery system (cds) was prepped but was not used.No additional information was reported.

Manufacturer Narrative

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

Manufacturer Narrative

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 the available information, the cause of reported difficult to insert is due to procedural conditions.Additionally, the reported perforation of vessels and hemorrhage are cascading effects of the reported difficult to insert.The reported perforation of vessels and hemorrhage, as listed in instructions for use (ifu) are known possible complication associated with mitraclip procedures.The reported unexpected medical interventions are the results of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.

• 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: 14697845
• MDR Text Key: 294045269
• Report Number: 2024168-2022-06415
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0702
• Device Lot Number: 11214R102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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): Required Intervention