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

Catalog Number SGC0705

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

Patient Problems Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report post procedure, tissue damage, thrombus and bleeding occurred.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing mr to 1-2.After the procedure, a piece of tissue was observed near the right atrium side of the interatrial septum.It was suspected that it was from the septal puncture.Follow up echocardiography confirmed thrombus in the right atrium derived from the tissue.The thrombus disappeared with antithrombotic therapy, but the patient had a mild cerebral hemorrhage due to the medication.The cerebral hemorrhage will be conservatively medically managed.Prior to the procedure, the patient presented to the hospital with acute heart failure due to mr.The patient remains hospitalized, but there is no adverse patient sequelae.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.Based on available information, the reported tissue injury appears to be due to procedural circumstances.The reported thrombus was associated with the damaged tissue.The reported intracranial hemorrhage was a cascading effect of the thrombus and the corresponding treatment provided.The reported patient effect of tissue injury and thrombosis, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 13481121
• MDR Text Key: 285239844
• Report Number: 2024168-2022-01275
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/22/2022

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: 06/21/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10621R202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 49 KG