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

Catalog Number SGC0705

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report a tear in the soft tip of the steerable guide catheter (sgc).It was reported that on (b)(6) 2022, a patient presented with grade 3 functional mitral regurgitation (mr).When the minus knob of the steerable guide catheter (sgc) was turned more than 300 degrees before inserting into the anatomy, the initial curve of the sgc was reversed and hyperextended.This caused a crease in the shaft of the sgc.It was returned within 270 degrees and inserted into the anatomy.Resistance was felt in the groin and the sgc was pushed in slightly, but could not be inserted smoothly.Upon checking, the soft tip was torn.To avoid damaging the vein, the sgc was replaced with a new one.The procedure was successfully completed, reducing the mr to grade <1.There was no adverse patient effect or clinically significant delay.No additional information was provided.

Manufacturer Narrative

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 complaints reported from this lot.The returned device analysis did not confirm the reported kinked steerable guide catheter (sgc) distal shaft or torn soft tip.However, the soft tip was observed to be deformed.The reported failure to advance could not be replicated in a testing environment.Based on available information, the observed deformed soft tip appears to be due to procedural conditions and is likely the damage originally reported.The reported failure to advance the sgc was a cascading event of the deformed sgc soft tip.The reported sgc shaft kink is possibly due to user perception, as this issue was not confirmed during returned device analysis.There is no indication of product issue with respect to manufacture, design or labeling.

• 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: 15610694
• MDR Text Key: 302952105
• Report Number: 2135147-2022-01629
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 20510R147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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
• Patient Age: 94 YR
• Patient Sex: Male
• Patient Weight: 45 KG