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

Model Number SGC0701

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/13/2022

Event Type  Injury  

Event Description

This is filed to report damage to the soft tip of the device and presence of thrombus.It was reported that on (b)(6) 2022, a patient presented with grade 4 degenerative mitral regurgitation (mr), history of aortic valve replacement, and a watchman left atrial appendage implant.During the procedure with a steerable guide catheter (sgc), the device was unable to cross the septum.Force was applied in effort to cross, but the sgc could not advance.The sgc was removed and damage was noted on the soft tip, as the surface was not smooth and appeared to be dented.The soft tip was fully intact.There was also a clot observed on the tip of the sgc.Additional heparin was administered and no additional treatments were needed.There was no adverse patient sequela.A guide catheter balloon was used on the septum, and a new sgc was able to pass successfully.The first xtw clip delivery system (cds) was advanced, and the shaft appeared to have an unusual bend while checking the trajectory of the clip.The cds curved to the medial side.There was speculation that the curve was due to the anatomy (aortic valve replacement).As a precautionary measure, the cds was removed and replaced.The clip was deployed and mr was reduced to grade 2.There were no adverse patient effects or clinically significant delays caused by any of the abbott devices.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.The investigation determined the reported failure to advance appears to be related to patient anatomy.The dented soft tip was due to the failure to advance.Thrombosis is listed in the instructions for use as known a possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstance.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 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: 15543184
• MDR Text Key: 301176985
• Report Number: 2135147-2022-01492
• 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,Followup
• Report Date: 12/06/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20420R247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 90 KG