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

Model Number SGC0701

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

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.The g4 clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed for unintended movement.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The patient anatomy included leaflet restriction between the posterior 2/posterior 3 leaflet segment.The steerable guide catheter (sgc) and clip delivery system (cds) were prepared for use and no issues were noted.The dilator was loaded into the sgc; however, it was difficult to advance the dilator through the sgc.The physician chose to continue with use of the same dilator and sgc.The device was advanced into the patient anatomy, and it seemed that the sgc was not tracking properly.Per physician, it seemed that the device was "dry"; however, it was confirmed that the device was flushed appropriately and all flush lines were properly connected.Additionally, it seemed that the sgc was bending/bowing unusually, and no unusual curves were on the device.The dilator crossed the septum, but the sgc did not.The decision was made to remove the device.There was no difficulty noted during removal and no adverse patient effect.A second sgc was used without issue.The cds was advanced into the patient anatomy to treat functional mitral regurgitation (mr) of grade 4.The pre-procedure mean pressure gradient was noted to be 4 mmhg.The clip grasped the leaflets without difficulty.Although mr was reduced to grade 2, it was noted that the mean pressure gradient increased to 14 mmhg.The decision was made to deploy the clip; however, after deployment, mr returned to grade 4 and the mean pressure gradient reduced to 11 mmhg.No additional clips were implanted.The patient is being considered for surgical mitral valve replacement.No additional information was provided.

Manufacturer Narrative

The returned device analysis did not confirm the reported difficult dilator advancement and unintended movement issue.The reported failure to advance- septum and activation, positioning or separation problem during use could not be replicated in a testing environment as it is related to patient anatomy/procedural operational circumstances.Furthermore, a kink on the steerable guide catheter (sgc) shaft was observed.The discrepancy between what was reported (difficult dilator advancement and unintended movement) and what was observed (no issue with advancement or unintended movement) was likely due to tension on the device during the procedure vs the return device analysis.Failure to advance sgc and activation, positioning or separation problem may be influenced by anatomical morphology/pathology, such as physical obstruction preventing the sgc from advancing forward, vessel tortuosity, a rotated heart or difficulties with the trans-septal puncture, etc.However, this cannot be confirmed in this case.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots that would have contributed to this event and a review of the complaint history identified no lot-specific product quality issue from this lot.Based on available information, a cause for the reported failure to advance- septum, difficult dilator advancement, unintended movement and activation, positioning or separation problem could not be determined.Additionally, the observed kink was a cascading event of the reported failure to advance.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11047533
• MDR Text Key: 222762831
• Report Number: 2024168-2020-10762
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00928U501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 50