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

Catalog Number SGC0705

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

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

Event Date 12/27/2021

Event Type  malfunction  

Event Description

This is being filed to report the tear in the sgc and difficulty removing the cds. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. One clip was successfully implanted. During insertion of the second clip delivery system (cds) the device was miskeyed; therefore the decision was made to remove the cds; however the clip became caught on the tip of the steerable guide catheter (sgc). Troubleshooting was performed and the cds was able to be removed however the sgc tip was torn. Another clip was successfully implanted, reducing mr to 2. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.

Manufacturer Narrative

The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional device is filed under a separate medwatch report number.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13223967
• MDR Text Key: 283762745
• Report Number: 2024168-2022-00358
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/10/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10510R147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/11/2022 Patient Sequence Number: 1

Treatment

1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM