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

Model Number SGC0701

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.The investigation has not yet been completed.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report damaged soft tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.It was noted septum was elastic and was pre-dilated with an unspecified balloon.Then a steerable guide catheter (sfc) was advancing but could not cross the septum.The soft tip of the sgc became damaged, a bit lifted.Therefore, the sgc was removed and the procedure continued with a new sgc.One clip was implanted, reducing mr to <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported damaged steerable guide catheter (sgc) soft tip was not confirmed via returned device analysis.The returned device analysis could not replicate the reported failure to advance the sgc across the septum in a testing environment as it is related to patient anatomy/procedural operational circumstances.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 incidents reported from this lot.Based on available information, causes for the reported failure to advance across the septum and the damaged sgc soft tip could not be determined.There is no indication of product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• 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: 12228856
• MDR Text Key: 263563086
• Report Number: 2024168-2021-06493
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10325R151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 97