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

Catalog Number SGC0705

Device Problems Product Quality Problem (1506); Unstable (1667); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

This is filed to report foreign material in the hemostasis valve.It was reported that during preparation of the steerable guide catheter (sgc), the thread on the flush port of the hemostatic valve appeared compromised and would not allow any device to be attached such as high pressure extension tubing and luer locks.There was no patient involved and no clinically significant delay.No additional information was provided.On 13 january 2023, the return device analysis found a mass of loctite (glue) in the hemostasis valve luer.

Manufacturer Narrative

All available information was investigated, and the returned device analysis confirmed the reported product quality problem and unstable luer as clear material was noted in the (id) inner diameter of the luer and the stopcock was unable to be connected to the luer.Therefore, an exception was initiated on 27-jan-2023 to evaluate whether a product issue exists.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would not have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the information reviewed and the returned device analysis, the observed loctite (device contamination with chemical or other material) inside the luer resulting in the reported product quality problem associated with the flush port being compromised and unstable luer (unable to connect the stopcock to the luer) appears to be related to a potential product quality issue.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
• 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: 16312583
• MDR Text Key: 309161716
• Report Number: 2135147-2023-00424
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 20909R1026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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