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

Model Number SGC0701

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Mechanical Problem (1384); Unstable (1667)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is being reported due to difficulty positioning, lack of knob manipulation and a suspected break.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr).There was difficulty advancing the steerable guide catheter (sgc) to the septum.The sgc was removed and dilation was attempted.After dilation, the sgc passed through the septum, but still was not responding.The physicians did not feel that when moving the guidebox anterior and posterior that the device was responding as expected.The sgc was removed and inspected for damage, but none was observed.A replacement sgc was used to complete the procedure with no patient consequences.No additional information was provided.

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.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on available information, the reported difficult or delayed positioning associated with the difficulty advancing to septum was related to procedural circumstances.Without the device to be analyzed, the cause for the reported positioning failure, mechanical problem, unstable (loose knob) associated with the sgc unresponsiveness in +/- directions could not be determined.A cause of the reported cable breakage could not be determined as this was a suspected event.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed report, additional information was received: the clip used with the replacement sgc could not be implanted due to a rise in gradient.Once the clip un-grasped the leaflets, the valve gradient returned to baseline.There were no patient consequences and no device issues.The procedure was ended unchanged with mr grade 3-4.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: 15949567
• MDR Text Key: 308245105
• Report Number: 2135147-2022-02459
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20303R248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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