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 04/05/2023

Event Type  Injury  

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, a cause for the reported perforation cannot be determined.Perforation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a perforation.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4.Two mitraclip xtw were implanted, reducing mr to a grade of 2.On (b)(6) 2023, the patient presented to the hospital.Echocardiography showed mr remained at a grade of 2 but an atrial septal defect (asd) was observed.No treatment was performed to treat the asd.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: 16808198
• MDR Text Key: 313932972
• Report Number: 2135147-2023-01809
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 11117R417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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): Hospitalization