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

Catalog Number SGC0702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is filed under separate medwatch report number.

Event Description

This is being filed to report the atrial septal defect requiring intervention.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019, to treat functional mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing mr to 2.The patient returned at a later date with the mr increased to 4.A second procedure was performed on (b)(6) 2021.During preparation of the clip delivery system (cds), the clip could not be inverted therefore the device was not used.The second clip delivery system (cds) was advanced and placed on the mitral valve.Post deployment it was noted the clip appeared to be opened more than the previously implanted clip.The procedure was concluded with the mr reduced to 2.The atrial septal defect was closed with an occluder.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.In this case, there was no reported device malfunction associated with the steerable guide catheter.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, a cause for the reported perforation could not be confirmed.The reported additional unexpected medical intervention was a result of case-specific circumstances.The reported patient effects of perforation, as listed in the mitraclip instructions for use (ifu), is a known possible complication associated with mitraclip procedures 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: 12166676
• MDR Text Key: 261483988
• Report Number: 2024168-2021-06031
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10222U324
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIP; 2 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention