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

Model Number SGC0701

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that the inability to straighten the steerable guide catheter tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.The patient from this procedure had heavy tortuosity in their femoral vein.There was difficulty in advancing the dilator and guide up through the vasculature and into the right atrium.The steerable guide catheter (sgc) and the dilator were advanced normally over the guide wire without success.The sgc was unable to navigate the bend.Contrast was applied into the formal vein to visualize any blockages and there were none.The guide wire was changed to a different guide wire.A buddy guide wire was used in the femoral vein to try and help straighten the vasculature in addition to the new guide wire.In doing this, the dilator was advanced out further and it allowed the sgc to advance through the vasculature and into the right atrium.The sgc was then advanced across the septum and into the left atrium (3 cm).The sgc was facing directly towards the pulmonary artery.When the physician tried to apply posterior and anterior guide torque to rotate the tip of the guide to a safer position the guide handle would rotate but the guide tip would not rotate.The guide handle was properly secured but the handle had resistance when trying to apply guide torque and when it was let go it settled back to neutral position slowly.Due to safety concerns around non-reliable steering, the sgc was removed.After the procedure, the sgc was noted to have significant set bends in the shaft from the vasculature which the physician attributed to causing the lack of rotation ability for the guide tip.There were no clips implanted as a clip could not be safely inserted in the left atrium as the guide was pointing towards the hear and would not respond to steering.The mr remained at 4.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

In this case, the returned device analysis could not replicate the difficult or delayed positioning in a testing environment due to procedural/operational circumstances, furthermore return device analysis was unable to confirm the reported positioning failure and the reported physical resistance/sticking of the knob.The reported kinked shaft was confirmed, as the distal braided shaft was observed to be bent.Additionally, the steerable guide catheter (scg) soft tip was observed to be torn.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 similar complaints reported from this lot.All available information was investigated, and a cause for the reported positioning failure and physical resistance/sticking of the knob could not be determined.The reported difficult or delayed positioning appears to be related to challenging patient anatomy.The kinked distal braided shaft was due to the difficult or delayed positioning-anatomy.The sgc soft tip tear appears to be due to user technique/ procedural conditions related to the difficult or delayed positioning-anatomy.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: 11378507
• MDR Text Key: 234987145
• Report Number: 2024168-2021-01460
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01120U143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEIER STIFF GUIDE WIRE; VERSA CROSS GUIDE WIRE
• Patient Age: 82 YR