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

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed due to access site complications.Patient id: (b)(6).It was reported that on (b)(6) 2021, a mitraclip procedure was performed for functional mitral regurgitation (mr), grade 4+.One mitraclip was successfully implanted, reducing the mr to grade 1+.On (b)(6) 2021, the patient presented to an outside emergency department for access site pain and swelling.An acute deep vein thrombosis (dvt) of the femoral vein and a superficial thrombosis of the saphenous vein were observed, secondary to the recent right femoral vein approach for the mitraclip procedure.Medications were provided and the patient was discharged home.No additional information was provided regarding this issue.

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.The reported patient effects of thrombosis, swelling/edema and pain are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on available information, a cause for the reported thrombosis could not be determined.The reported pain and swelling appear to be a cascading effect of thrombosis.The reported medication was a result 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: 13487882
• MDR Text Key: 286560925
• Report Number: 2024168-2022-01312
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10802R125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 83 KG