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

Catalog Number SGC0702

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Shock (2072); Tachycardia (2095); Perforation of Vessels (2135)

Event Date 02/24/2022

Event Type  Death  

Event Description

This is filed to report the patient death. It was reported that a mitraclip procedure was performed to treat functional grade 3+ mitral regurgitation (mr). The steerable guide catheter (sgc) was inserted in right femoral vein over the guidewire. Resistance was felt with the femoral vein, the sgc was removed, and the femoral vein was predilated once again followed by sgc insertion under fluoroscopic guidance. When the tip of sgc was placed into left atrium, the patients¿ blood pressure lowered to systolic 65mmhg. No injury was observed. The procedure was continued, one clip was implanted, reducing mr to <1. Blood pressure was stable throughout the rest of procedure around 90-110mmhg with normal heart rhythm. Volume contrast imaging (vci) was injected through the sgc flush port while retracting sgc into femoral vein. Extravasation was noted at the femoral vein/ iliac vein. A 22mmx112mm stent graft was placed and surgical intervention were attempted to treat the vein injury; however, extravasation did not stop. Blood pressure dropped, the heart rhythm increased, massive bleeding was noted which at the end could not be stopped or repaired despite all efforts. The patient went into shock, no treatment was possible resulting in death. Per the physician, it cannot be determined which device caused the injury and patient death, it could be related to a combination of catheter(s)/ wire manipulation(s), sgc insertion, and or pre-existing anatomy. No additional information was provided.

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.

• 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: 13773007
• MDR Text Key: 287240711
• Report Number: 2024168-2022-02670
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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

• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SGC0702
• Device Lot Number: 10914R144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/15/2022 Patient Sequence Number: 1