MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Catalog Number SGC0702

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported during preparation of a steerable guide catheter (sgc), the flush port was observed to be broken, resulting in a leak while de airing.Therefore, the sgc was not used and replaced.There was no clinically significant delay in the procedure.

Manufacturer Narrative

All available information was investigated, and the reported leak and broken flush port could not be replicated in a testing environment.Additionally, the flush port luer was not returned.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.Based on available information, the reported leak was a cascading event of the reported broken flush port.The reported missing flush port luer was due to post-procedural handling as the luer was not returned for device analysis.The investigation determined the reported broken sgc hemostasis valve flush port to be related to a potential product quality issue.This complaint is within the scope of an exception escalation as the complaint description and device code match the specific issue described in the exception.Therefore, exception (issue) 127621 and exception (action) 132488 are referenced.The investigation evaluated the reported issue, and the engineering group determined the potential root cause to be mother nature in the form of environmental stress cracking (esc).The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18896959
• MDR Text Key: 337585067
• Report Number: 2135147-2024-01112
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231032
• UDI-Public: (01)08717648231032(17)241009(10)31011R1086
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0702
• Device Lot Number: 31011R1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1