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

Model Number SGC0701

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

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 clip referenced are filed under a separate medwatch report number.

Event Description

This is filed to report during preparation, the sgc failed to hold water column.It was reported that the initial mitraclip procedure was performed on (b)(6) 2017 to treat functional mitral regurgitation (mr).One clip was implanted in the center a2/p2 reducing mr.On unspecified date, the patient presented with shortness of breath and mr grade of 4+.Echocardiography showed there was an anterior flail at the medial section of a2/p2 next to the clip where one jet was forming.On (b)(6) 2021, a second procedure was performed.During preparation of the steerable guide catheter (sgc) it was noted that the cap of the dilator was unable to fully close and the sgc failed to hold fluid column; therefore, the sgc was not used in the procedure.A new sgc was used to safely continue the procedure.A clip delivery system (cds) was advanced to the mitral valve and the clip was implanted medial a2/p2 next to the previous implanted clip, reducing mr to 1-2.The patient¿s initial gradient was 3 mmhg and ending gradient was 6 mmhg; however, the physician was pleased with the results.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 this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the report that the cap of the dilator was unable to fully close.The reported leak appears to be due to the cap unable to fully closed; therefore, attributed to procedural condition.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: 12492018
• MDR Text Key: 272138092
• Report Number: 2024168-2021-08262
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10211U144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1