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

Catalog Number SGC0702

Device Problems Break (1069); Difficult to Insert (1316); Leak/Splash (1354)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, almost non-existing medial posterior mitral leaflet, on a fragile patient, with a previous endocarditis.While inserting a mitraclip ntw clip delivery system (cds) and steerable guide catheter (sgc), resistance was encountered, requiring more effort.It was then observed that the sgc was empty.Therefore, the sgc was removed and replaced.However, with the new sgc, it was observed that the sgc was empty.Therefore, the clip was removed and replaced.The same sgc was used with a new mitraclip ntw.The mitraclip ntw was implanted, reducing the mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Manufacturer Narrative

Returned device analysis did not confirm the reported hemostasis valve break.The reported leak/splash associated with a loss of fluid column was confirmed.It was however, noted that the silicone valve inside the sgc hemostasis valve was torn.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and based on the information provided and the analysis of the returned device, the reported leak appears to be related to the observed tear in the silicone valve of the sgc hemostasis valve that likely occurred during difficult clip delivery system (cds) insertion.The reported hemostasis valve break appears to be related to user perception for the cause of the leak.There is no indication of a product issue with respect to manufacture, design, or labeling.H6 medical device problem codes 1316 was removed.Code 1069 was added.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

Subsequent to the previously filed report, additional information was received.The leak in the steerable guide catheter (sgc) was caused by the clip delivery system (cds).Difficulty with insertion was due to the cds.After the procedure, the valve on the sgc was observed to be broken.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• 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: 18800670
• MDR Text Key: 336508560
• Report Number: 2135147-2024-00916
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231032
• UDI-Public: (01)08717648231032(17)241111(10)31113R1005
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0702
• Device Lot Number: 31113R1005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• 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