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 Problems Fistula (1862); Diminished Pulse Pressure (2606)

Event Date 03/30/2021

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

This is filed to report the arteriovenous fistula which was detected after the procedure.It was reported that there was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.When the steerable guide catheter (sgc) was introduced a fistula was created at the femoral level.The fistula was monitored and no hematoma was present.The patient was stable throughout the case.Two clips were implanted, reducing mr to 1+.At the close of the case, the sgc was removed and a fistula in the right femoral vein/artery was confirmed and treated with an additional procedure.The fistula was stented, and arterial flow returned to normal.The patient remained stable throughout this process and continues to be stable.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 the reported event.Based on the available information, the reported fistula appears to have been a result of procedural conditions.The reported diminished pulse appears to have a result of the reported fistula.The reported patient effect of fistula, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6.Patient code 2606 added.

Event Description

Revised description it was reported that there was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.When the steerable guide catheter (sgc) was introduced a fistula was created at the femoral level.The physician felt it happen and monitored the site as no hematoma was present and the patient was stable throughout the case.Two clips were implanted, reducing mr to 1+.At the close of the case the sgc was removed and perclose suture tightened down.When the patient was being prepared to be removed from the table a "dusky" color was noted on the patient's leg and a distal pulse could not be palpated.Hemostasis was not fully achieved, and he ordered a femstop.After the procedure, a fistula in the right femoral vein/artery was discovered.The patient required an additional procedure to repair the fistula.The fistula was stented, and arterial flow returned to normal.The patient remained stable throughout this process and continues to be stable.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
• MDR Report Key: 11686687
• MDR Text Key: 246058976
• Report Number: 2024168-2021-03261
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10112U104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 137