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

Model Number N/A

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

Patient Problem Perforation (2001)

Event Date 07/14/2022

Event Type  Injury  

Event Description

This is filed to report the atrial septal defect.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022, to treat degenerative mitral regurgitation (mr) with a grade of 4.The transseptal puncture was suboptimal.One mitraclip was implanted successfully.A second clip was advanced and attempted to be placed at a2p2 lateral to the first clip.While adjusting the clip under the valve by 10 degrees, the clip became caught in the chords.The clip was unable to be unstuck and a grasp was attempted.The leaflet became stuck behind the gripper.Minor adjustments were made, and the grippers were cycled to become unstuck.An attempt was made to move back to the left atrium (la).However, due to the limited height of the transseptal puncture there was difficulty getting back to the la even with under straddling.It was suspected the clip was stuck in the chords due to lost height.A good grasp was obtained, and the clip was deployed.Two clips total were implanted reducing the mr to 1.When the steerable guide catheter was pulled across the septum it was noted that the septum was torn there was a large atrial septal defect (asd).The flow was left to right, so the asd was left untreated.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the atrial perforation (asd/atrial septal defect) appears to be related to procedural conditions.Perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The minor injury/ illness / impairment was a result of case-specific circumstances, as no treatment was provided.There is no indication of a product issue with respect to manufacture, design or labeling.The mitraclip device referenced is filed under a separate medwatch report number.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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: 15154173
• MDR Text Key: 297187191
• Report Number: 2024168-2022-08496
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2022

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: 02/17/2023
• Device Model Number: N/A
• Device Catalogue Number: SGC0701
• Device Lot Number: 20216R747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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: IMPLANTED MITRACLIP (X2)
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White