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

Catalog Number SGC0702

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not returning for evaluation.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 soft tip damage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with an mr grade of 3-4.Attempts to advance the steerable guiding catheter (sgc), up to the femoral vein were unsuccessful.Resistance was felt with the anatomy.The sgc was removed without issue.The soft tip was slightly damaged, and a kink was noted on the sgc shaft.A new sgc was used.One clip was implanted, reducing mr to 1.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 that would have contributed to this event.Additionally, a review of the complaint history identified no lot specific product issue.All available information was investigated, and the reported failure to advance was a result of procedural circumstance/operational context.The reported deformation due to compressive stress (soft tip/shaft) was cascading event that resulted due to failure to advance the sgc device.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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12059723
• MDR Text Key: 259411547
• Report Number: 2024168-2021-05383
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10204U139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1