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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2020

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 additional mitraclip device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report leak.It was reported that prior to the procedure, the steerable guide catheter (sgc), would not hold column during preparation.The sgc was tested three more times, but failed to hold saline.Additionally, during preparation of the clip delivery system (cds), the clip opened while locked when establishing the final arm angle/efaa.The clip was tested three additional times, but the clip would still open when locked.However, the patient experienced a pericardial effusion (pe) after the transseptal puncture was performed and the procedure was aborted.Therefore, replacement devices were not used.The sgc and cds was not used in the patient.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and a definitive cause for the reported leak in this complaint could not be determined.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: 10961324
• MDR Text Key: 220228514
• Report Number: 2024168-2020-10229
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00928U956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1