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

Model Number SGC0701

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

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

Event Date 08/04/2021

Event Type  malfunction  

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 filed to report a torn soft tip it was reported that on (b)(6) 2019, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.An ntr clip was placed on the mitral valve, reducing mr to a grade of 1.On an unknown date, the patient returned to the hospital and echocardiography showed mr had increased to a grade of 4.The clip remained stable and the physician stated the recurrent mr was due to a progression of disease.On (b)(6) 2021, an additional mitraclip procedure was performed.The steerable guide catheter (sgc) was inserted, but was unable to pass through the septum.Therefore, the sgc was removed.Upon removal, it was observed the soft tip had become torn.A new sgc was inserted without issues and one clip was placed on the mitral valve, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay occurred.No additional information was provided.

Manufacturer Narrative

In this case, the returned device analysis confirmed the reported torn soft tip.The reported failure to advance could not be replicated in the testing environment as it was related to patient/procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not identify any similar incidents.Based on the information reviewed, the reported failure to advance was due to procedural conditions.The reported torn soft tip was a consequence of the reported failure to advance.There is no indication of a product issue with respect to manufacture, design or labeling.H6 health effect - impact code 2645 was removed and code 2199 was added.

• 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: 12336828
• MDR Text Key: 267089779
• Report Number: 2024168-2021-07248
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10224U147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP; IMPLANTED MITRACLIP