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

Catalog Number SGC0702

Device Problems Break (1069); Positioning Failure (1158); Failure to Advance (2524)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the possible steerable guide catheter cable break.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with an mr grade of 3.When inserting the steerable guiding catheter (sgc) (10115u112), into the pelvis through the femoral vein, the sgc did not advance due to a narrow point in the pelvis.The sgc was removed without issue.Once outside of the anatomy, the sgc was rinsed and the +/- knob was tested.It was observed that the sgc no longer curved with the +/- knob, possibly a cable break.A new sgc was prepped and was inserted.The sgc did not advance in the pelvis towards the septum.The sgc was removed and the procedure was aborted.No clips were implanted, mr remains at 3.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not identify any similar incidents.Based on the information reviewed, the reported failure to advance was due to the patient¿s anatomical challenges.The reported break, positioning failure (curve ¿ unable) were likely cascading effects of the attempts to advance the steerable guide catheter/sgc through the challenging anatomy.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12294748
• MDR Text Key: 265614088
• Report Number: 2024168-2021-06969
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10115U112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1