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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Product Quality Problem (1506)

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

Event Date 06/08/2023

Event Type  Injury  

Event Description

This is filed to report intervention.It was reported that a patient presented with grade 4 functional mitral regurgitation.During a mitraclip procedure, it was noted that the transition between the soft tip of the steerable guide catheter (sgc) and the dilator was more prominent than usual.Inserting the sgc was noted to be difficult.The femoral vein was dilated with a 22 and 24 french dilator, and the sgc was able to be inserted.After a successful procedure, it was noted that one of the standard sutures close to the puncture site was damaged by the prominent edge of the sgc.This required additional suturing with 2 proglide devices.There was a delay of 20 minutes due to the difficulty, but it was not clinically significant.There were no adverse patient effects.One mitraclip, reduced the mr to grade 1-2.No additional information was provided.

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 difficult to insert (anatomy) could not be replicated in a testing environment.The reported product quality problem (irregular appearance) was not confirmed via device analysis.Additionally, the soft tip was observed to have minor deformation.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 observed deformation due to compressive stress associated with the minor soft tip deformation appears to be due to the insertion difficulty.The cause of the reported product quality problem (irregular appearance) associated with the prominent transition between the soft tip and dilator, and the reported difficult to insert (anatomy), could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17216681
• MDR Text Key: 318021440
• Report Number: 2135147-2023-02825
• Device Sequence Number: 1
• Product Code: DRA
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30131R1097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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
• Treatment: MITRACLIP
• Patient Outcome(s): Required Intervention