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

Catalog Number SGC0705

Device Problem Unstable (1667)

Patient Problems Hemorrhage/Bleeding (1888); Shock (2072)

Event Date 08/04/2021

Event Type  Injury  

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.

Event Description

This is being filed to report the bleeding requiring transfusion, shock and hospitalization.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The steerable guide catheter (sgc) was advanced however during the procedure, bleeding was noted from the groin therefore a blood transfusion was performed.The procedure was continued and it was noted that when rotating the handle from the middle, only the handle moved, the shaft did not move.The sgc was reset on the stabilizer however the same issue occurred therefore the sgc was removed and replaced with a new one.One clip was implanted, reducing mr to 3-4.Post procedure the patient went into shock due to the loss of blood and an intra-aortic balloon pump (iabp) was placed.On 8/5/2021 the iabp was removed and the patient was tracheal intubated and remains hospitalized.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported loose/unstable handle (when rotating the handle from the middle, only the handle moved, the shaft did not move) and observed the handle adapter to be loosed and not secured to the handle hypotube.In additions, the glue fillet on the screw of the adaptor was backed out and the handle screw was not fully tightened within the adaptor.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 similar complaints reported from this lot.The reported hemorrhage appears to be related to procedural conditions.The reported shock was a cascading effect of the bleeding.Hemorrhage and shock are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical interventions and hospitalization were results of case-specific circumstances.The investigation determined the reported unstable handle and observed glue fillet backing out appear to be related to the observed loosed screw.The loosed screw appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12332264
• MDR Text Key: 266919780
• Report Number: 2024168-2021-07215
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10212U114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 53