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 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This will be filed to report soft tip damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 3.During insertion of the steerable guide catheter (sgc) there was resistance; therefore, the sgc was removed.After the sgc was pulled out, it was noticed that there was a slight deformation of the sgc tip.The angled part of the sgc was wavy and the soft tip was worn out but not torn.Therefore, a new sgc was used successfully in the procedure.One clip was implanted, reducing mr to 1.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed a bent steerable guide catheter (sgc) shaft.However, the reported difficult to insert could not be replicated in a testing environment as it is related to patient anatomy/procedural operational circumstances.Additionally, the reported bent/damage on sgc tip could not be confirmed.Based on available information, a cause for the reported difficult to insert and damage on soft tip could not be determined.The reported bent was cascading events of the difficult to insert.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: 12345246
• MDR Text Key: 267443901
• Report Number: 2024168-2021-07323
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10210U431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1