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.

Manufacturer Narrative

The reported difficult or delayed positioning-anatomy during use could not be replicated in a testing environment as it was related to patient anatomy or procedural operational circumstances.The reported kink on the shaft was confirmed in returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no lot-specific product issue from this lot.Based on available information, reported resistance (difficult or delayed positioning) while inserting and kink on shaft issue appear to be due to challenging patient anatomy.There is no indication of product issue with respect to manufacture, design or labeling.

• 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: 12160970
• MDR Text Key: 261489417
• Report Number: 2024168-2021-06013
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM