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

Catalog Number SGC0705

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Leak/Splash (1354); Physical Resistance/Sticking (4012)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

This is filed to report inability curve and a leak.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An ntw clip (21019r1004) was inserted, but while grasping, it was observed one of the grippers was not functioning as intended.Therefore, the clip was removed and replaced.An additional ntw (21019r1006) was inserted.However, the resistance was felt when turning the steerable guide catheter (sgc) handle an an aortic hugger was observed.The sgc was then unable to move in an anterior or posterior direction.A leak from the sgc handle then occurred; therefore, the sgc and clip delivery system (cds) were removed.The physician then stated the ntw clip that was selected was the incorrect size.A new sgc was used and an xt clip was deployed, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.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 number.

Manufacturer Narrative

All available information was investigated, and the reported difficult or delayed positioning (anatomy) and physical resistance / sticking could not be replicated in a testing environment.The reported positioning failure (curve - unable) and positioning failure (straighten - unable) could not be confirmed via device analysis.The reported leak / splash was confirmed via device analysis.Additionally, the sgc shaft was noted to be deformed.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 did not indicate a lot-specific quality issue.Based on available information, the reported difficult or delayed positioning (anatomy) associated with the aorta hugger appears to be due to procedural circumstances during device advancement.The reported physical resistance / sticking associated with the resistance when torquing the sgc handle, the reported positioning failure (curve - unable) / positioning failure (straighten - unable) associated with the difficulty moving the sgc anterior and posterior, and the observed deformation due to compressive stress associated with the deformed sgc shaft, appear to be due to procedural circumstances (device interacting with patient pathology/ morphology).The reported/ observed leak / splash associated with the handle leaking fluid was identified to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• 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: 16756093
• MDR Text Key: 313452886
• Report Number: 2135147-2023-01685
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 21012R1005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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
• Treatment: CLIP DELIVERY SYSTEM.; STEERABLE GUIDE CATHETER.