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

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Fistula (1862); Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).This is filed for pseudoaneurysm, fistula, requiring intervention.It was reported that this was a mitraclip procedure, performed on (b)(6) 2021, treating functional mitral regurgitation (mr) with a grade of 4.Two clips were implanted and the mr was reduced to grade 1+.On (b)(6) 2021, the patient was re-hospitalized with pseudoaneurysm and arteriovenous fistula noted at the proximal superficial femoral artery and vein.Thrombin injection was administered and the patient became unresponsive, with atrial fibrillation.Intravenous fluids were administered and the patient became more responsive, with some confusion.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 the reported issue.There are no related effects to the mitraclip device or procedure reported.There is no indication of a product quality issue with respect to manufacture, design or labeling.B2: an adverse event related to the steerable guide catheter did not occur.H6: health effect - clinical code: 1862, 1729, 2605 - removed.H6: health effect - impact code: 4607, 4644 - removed.

Event Description

Subsequent to the initial report, additional information was provided.Per study physician, the unresponsiveness, pseudoaneurysm and arteriovenous fistula, with related effects/treatments, are unrelated to the mitraclip devices.Although the unresponsiveness, pseudoaneurysm and arteriovenous fistula, with related effects/treatments are not related to the mitraclip device or procedure, this event has been reported; therefore, it will remain reportable.No additional information was provided.

• 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: 12485131
• MDR Text Key: 271871552
• Report Number: 2024168-2021-08227
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10309U147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 54