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 Problem Thrombosis/Thrombus (4440)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombus is listed in the mitraclip g4 system instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Based on available information, a cause for the reported thrombus could not be determined.The reported required medication is the 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 for thrombosis.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) of grade 4+.The patient was administered 5000 units of heparin and the activated clotting time (act) was greater than 400.The guide wire was advanced into the anatomy and across the septum without issue.The steerable guide catheter (sgc) was advanced into the patient anatomy without issue; however, when the sgc reached the right atrium, a large clot was noted on the guide wire in the right atrium.The sgc was removed and additional heparin was administered.The sgc was re-prepped for re-insertion; however, it was noted that the clot remained.A full dose of angiomax was administered, but the clot remained.The decision was made to abort the procedure and monitor the patient condition.At the end of the procedure, the patient was in stable condition.The plan is to have the patient return to the operating room for transesophageal echocardiogram (tee).If the clot remains, additional intervention will be performed.No additional information was provided.

• 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: 13896382
• MDR Text Key: 288309587
• Report Number: 2024168-2022-03152
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10922R248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 100 KG