MAUDE Adverse Event Report: ABBOTT MEDICAL 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 02/21/2023

Event Type  Injury  

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.Based on available information, the reported perforation associated with the asd appears to be due to procedural circumstances (device interacting with patient pathology/ morphology).The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported surgical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip referenced in description of event or problem will be filed under a separate medwatch report number.

Event Description

This is filed to report atrial perforation requiring intervention.It was reported that a mitraclip procedure was performed on (b)(6) 2023 to treat degenerative mitral regurgitation (mr) grade 4+.An xtw clip (21213r1043) was implanted lateral with good imaging and a ntw clip (21006r2089) was implanted medially with challenging imaging due to patient anatomy and shadowing.The procedure was complete with an mr of grade 2.The clips were attached to both leaflets, but there was a lot of motion due to the large posterior prolapse.On (b)(6) 2023, when the follow-up echocardiogram was performed, an atrial septal defect (asd) was observed.It was thought this was due to the steerable guide catheter (sgc).On (b)(6)2023, the patient presented with recurrent mr grade 4 around the lateral xtw clip (21213r1043).This was discovered as the patient was scheduled for an asd closure procedure.Further evaluation revealed that the posterior leaflet was ruptured around the xtw clip, but the clip still remained attached to a small part of the posterior leaflet.The medial ntw clip (21006r2089) remained stable on both leaflets and had no evidence of tissue damage.An additional mitraclip was planned to be implanted to stabilize and reduce mr.The steerable guide catheter was advanced to the left atrium.However, before the clip was prepared, it was decided that mitraclip intervention was not possible due to the leaflet perforation.It was decided that there was not a sufficient area to grasp the posterior leaflet.The intervention was aborted, along with the asd closure.Mr remained at grade 4.On (b)(6)2023 the patient underwent mitral valve replacement surgery and the asd was also repaired.The patient is stable.No additional information was provided.

• 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: 16541404
• MDR Text Key: 311289720
• Report Number: 2135147-2023-01187
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/14/2023

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: 10/18/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 21019R2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: 2 IMPLANTED MITRACLIPS.
• Patient Outcome(s): Required Intervention; Hospitalization