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

Model Number SGC0701

Device Problem Off-Label Use (1494)

Patient Problem Thrombosis (2100)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional device is filed under a separate medwatch report number.

Event Description

This is filed to report thrombus.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 4+.The clip delivery system (cds) was inserted; however, before the clip exited the steerable guide catheter (sgc), a large thrombus was noticed on the tip of the sgc.It was noted that the activated clotting time (act) remain above 250 throughout the procedure.The cds was removed; however, once the clip was removed, thrombus was noticed all around the clip.Aspiration was them performed, but it was then noted that the sgc had thrombus inside the clear chamber.A 16fr sheath was inserted and additional heparin was administered while removing the sgc.The thrombus had been resolved; therefore, a new sgc and cds were inserted without issues.The clip was successfully implanted, reducing tr to a grade of 1-2.There was no clinically significant delay in the procedure.

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.It should be noted that the mitraclip instructions for use (ifu) states: the mitraclip g4 system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation.Based on the information reviewed, the reported off-label use of the device was associated with the procedure being performed on the tricuspid valve; however, in this case, it cannot be determined if the off-label use contributed to the reported thrombus.A cause for the thrombus could not be determined in this case; however, thrombosis is listed in the mitraclip ifu as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10515287
• MDR Text Key: 206349053
• Report Number: 2024168-2020-07545
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00623U601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention