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

Catalog Number SGC0702

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 12/13/2021

Event Type  Injury  

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.

Event Description

It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced, and the clip was implanted successfully reducing mr to 1.When the steerable guide catheter was withdrawn to the right atrium, the patient's blood pressure dropped and tachycardia occurred.Echocardiogram showed a moderate to severe pericardial effusion.Medication was given and pericardiocentesis was performed successfully, and the patient was transferred to intensive critical care unit.The patient was reported to be doing well.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 the available information, a cause for the reported hypotension and pericardial effusion could not be determined.The reported tachycardia was due to reported hypotension.The reported patient effects of hypotension, pericardial effusion and tachycardia are listed in the instruction for use (ifu) as known possible complications associated with mitraclip procedures.The reported medical intervention, hospitalization and required medication was a result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.E1.Initial reporter.

• 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: 13177105
• MDR Text Key: 283319241
• Report Number: 2024168-2022-00161
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10716R111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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