MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

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

Patient Problem Thrombosis (2100)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record did not identify any manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc).Based on the information reviewed, a definite cause for the reported thrombosis could not be determined.The reported patient effect of thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report thrombosis.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.A steerable guide catheter (sgc) was advanced to the mitral valve; however, a clot was observed prior to the clip delivery system entering the patient.The thrombosis was not removed and treatment was not provided.The physician stated the thrombosis is not related to the sgc, but this cannot be confirmed.The sgc was removed and the procedure was aborted.No clips were implanted, and mr is 4.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 9842860
• MDR Text Key: 186735026
• Report Number: 2024168-2020-02539
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91112U248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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): Other
• Patient Age: 70 YR
• Patient Weight: 75