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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report kinked soft tip.It was reported that this is a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3+.It was noted thick pathology.The steerable guide catheter (sgc) could not be inserted into the groin.The quality of the imaging was changed to contrast medium.Although there was no issues observed with the vessel, the sgc soft tip became kinked.A decision was made not use the sgc and the procedure was successfully completed with a new sgc.One clip was implanted, reducing mr to <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the returned steerable guide catheter (sgc) did not confirm the reported soft tip kink as no issues were noted.The reported difficult to insert could not be replicated in the testing environment and it was likely an outcome of user technique/procedural circumstance.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and a conclusive cause for the reported soft tip kink could not be determined in this complaint.The reported difficult to insert was an outcome of challenging patient anatomical condition.The observed sgc shaft kink was a cascading effect of the reported difficulty inserting the sgc.Based on the information reviewed, 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: 12533129
• MDR Text Key: 273347733
• Report Number: 2024168-2021-08621
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10226U112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1