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

Catalog Number SGC0702

Device Problems Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device is reportedly in transit to abbott for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional device referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report the kink in the soft tip of the steerable guide catheter. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3. During advancement of the steerable guide catheter (sgc) narrowing of the vein caused resistance and damage/kink to the soft tip of the device. The damage was not noticed, however, until the clip delivery system (cds) was advanced and the cds could not be straightened or curved due to the damage to the sgc. Both devices were removed and replaced with new ones. One clip was implanted, reducing mr to 1. There was no clinically significant delay in the procedure and no adverse patient effects. 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
• 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: 12160970
• MDR Text Key: 261489417
• Report Number: 2024168-2021-06013
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/04/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10204U108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial