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

Catalog Number SGC0702

Device Problem Difficult to Advance (2920)

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

Event Date 03/08/2022

Event Type  Injury  

Event Description

This is being filed to report the ruptured vein requiring surgery.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted however resistance was met.The sgc was removed and under fluoroscopy a loop was visible in the guide wire.The loop was removed and the4 sgc was inserted and advanced without issue.One clip was successfully placed, reducing mr to <1.After the procedure the patient had severe bleeding and a rupture of the femoral vein was noted.The vein was surgically fixed however the patient required prolonged hospitalization.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.

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 did not indicate a lot-specific quality issue.Based on the information reviewed, the reported difficult to advance appears to be related to procedural condition.The reported perforation of vessel (rupture of the femoral vein) appears to be related to difficult to advance.The hemorrhage was a result of the reported perforation of vessel.Additionally, hemorrhage and perforation of vessels are listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The prolonged hospitalization and surgical intervention were a result of case-specific circumstances.There is no indication of a 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: 13929404
• MDR Text Key: 288036922
• Report Number: 2024168-2022-03207
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10921R225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention