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 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report leak.It was reported that during preparation of a steerable guide catheter (sgc), the column would not hold fluid.The sgc was not used in the patient.The procedure continued with a new sgc.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak was not confirmed during return device analysis as no issues were noted during testing.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.A conclusive cause for the reported leak could not be determined in this complaint.Based on the information reviewed, 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: 10961059
• MDR Text Key: 220240963
• Report Number: 2024168-2020-10227
• 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: 02/18/2021

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: 10/01/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00928U751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1