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

Model Number N/A

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported thrombosis/thrombus cannot be determined; however thrombosis is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The medication required and unexpected medical intervention were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a thrombus.It was reported that on (b)(6) 2022 three mitraclips were implanted during a procedure to treat degenerative mitral regurgitation (mr) grade 4.The procedure reduced the mr to grade 1.Due to decompensation, the patient was hospitalized.The mr had returned to grade 4.All three clips were observed to be stable on the leaflets.Per the physician the increase in mr was due to progression of disease.On (b)(6) 2022 another clip was to be implanted to reduce the mr.When the steerable guide catheter (sgc) was in the right atrium, a thrombus was observed.Physician applied additional heparin and aspirated the thrombus successfully via the sgc.Sgc was removed out of the patient and flushed again.A fourth clip was then successfully implanted reducing the mr to grade 2.There was no clinically significant delay.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15284020
• MDR Text Key: 298502011
• Report Number: 2135147-2022-00879
• 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
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: N/A
• Device Catalogue Number: SGC0702
• Device Lot Number: 20316R301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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: 3 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention