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

Model Number SGC0701

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

Patient Problem Atrial Perforation (2511)

Event Date 11/03/2020

Event Type  Injury  

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 being filed to report that after removal of the steerable guide catheter (sgc), a left to right and right to left shunting at the septum was observed.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.One clip was successfully implanted clip reducing mr to 2-3.When the steerable guide catheter (sgc) was retrieved to the left atrium, a right to left shunt occurred due to the torrential tricuspid regurgitation.Therefore, an atrial septal defect (asd) occluder was implanted for treatment.Mr remained a grade of 2-3 and the patient was confirmed stable post procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the available information, the reported atrial perforation appears to be due to challenging patient anatomy.The reported patient effect of atrial perforation as listed in the mitraclip system gen 4 instructions for use, is a known possible complication associated with mitraclip procedures.The therapy / non-surgical treatment, additional, was a result of case-specific circumstances.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: 10899794
• MDR Text Key: 218241865
• Report Number: 2024168-2020-09888
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00915U132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 102