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

Model Number SGC0701

Device Problem Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 02/14/2023

Event Type  Injury  

Event Description

This is filed to report a tear in the septum.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.The steerable guide catheter (sgc) was unable to cross the septum.The transseptal puncture was dilated via a balloon, allowing the sgc to successfully pass through.One mitraclip was successfully implanted reducing the mr to a grade of <1.At the end of the procedure, a tear in the septum was observed along with a left to right shunt.There was no device issues with the sgc and no treatment was provided.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 this event.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.Based on the available information and without the device to analyze, the reported difficult to advance the sgc through the septum cannot be determined.The cause of the reported perforation is due to the procedural conditions.Additionally, the reported patient effect of perforation is listed in the instructions for use (ifu) and is a known possible complication associated with mitraclip procedures.The reported minor injury/ illness/ impairment was a result of case-specific circumstances.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 MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16505695
• MDR Text Key: 310910753
• Report Number: 2135147-2023-01074
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20927R1043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP XT.
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG