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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

This is filed to report a leak.It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with a grade of 4 and a broad jet.During device preparation of the steerable guide catheter (sgc), column failed to hold twice during insertion of the dilator.The scg was not used in the patient and was exchanged for another sgc to continue the procedure.One mitraclip xtw was implanted reducing the mr to a grade of 1.The gradient increased from 5mmhg to 6mmhg, however the physician was satisfied with the results.There was no clinically significant delay in the procedure and no adverse patient effects.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 record identified no manufacturing nonconformities issued to the reported lot.A review of the complaint history did not indicate a lot-specific product issue.Based on available information, a cause for the reported leak could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previously filed report, additional information was received: it was reported that when the xtw clip was deployed the gradient increased to 6mmhg; however, the physician accepted the results because the patient was in an irregular and elevated heart rhythm.The irregular and elevated heart rhythm was not related to the mitraclip device.The patient had a pre-existing condition of atrial fibrillation during admission and during the procedure.

• 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: 15973645
• MDR Text Key: 308483293
• Report Number: 2135147-2022-02521
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: N/A
• Device Catalogue Number: SGC0701
• Device Lot Number: 20602R147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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 Age: 48 YR
• Patient Sex: Female