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

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

This is filed to report the loss of glue fillet bond.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.During implantation of the first clip, it was noted that the steerable guide catheter (sgc) had difficulty steering in the anterior and posterior directions.Troubleshooting assisted the implantation and the clip was implanted.The sgc was replaced before implanting a second clip reducing the mr to a grade of <1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.In addition, the returned device analysis noted that the glue fillet bond was not securely attached in the adaptor of the handle.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported unintended movement was confirmed via returned device analysis.Additionally, the steerable guide catheter (sgc) handle adaptor was observed to be unstable, indentation and scratches from the set screw was present on sgc hypotube and the adhesive on the set screw had backed out.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 from this lot.Based on available information and the results of the analysis, the reported sgc unintended movement appears to be due to the observed unstable (handle adaptor).The investigation identified the observed handle adaptor instability, scratched sgc hypotube and the loss of bonding (backed out adhesive) 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: 15439786
• MDR Text Key: 302276073
• Report Number: 2135147-2022-01231
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2023
• Device Model Number: N/A
• Device Catalogue Number: SGC0705
• Device Lot Number: 20210R310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2022
• 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
• Treatment: 1 IMPLANTED MITRACLIP.
• Patient Age: 84 YR
• Patient Sex: Male