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

Model Number SGC0701

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/19/2021

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.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report torn tip.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed.However, mr did not change.A second cds (00818u214) was advanced to the mitral valve, and the clip was grasped the leaflets fine.However, the mean pressure gradient increased to 8mmhg.Therefore, the clip un-grasped the leaflets to remove the cds from the patient.But, when the clip was retracted back into the tip of the steerable guide catheter (sgc), the clip became stuck at the guide tip.It was noted that the physician inadvertently did not lock the clip during removal of the cds.The cds and sgc were both retracted back to the groin and the sgc was removed.However, the tip of the sgc became torn and the clip became stuck in tissue.Due to the clip not being locked, the clip was inverted, but the mandrel broke and the clip became detached, but remained attached to the gripper and lock lines.Tissue damage was observed resulting a clinically significant delay in the procedure.Therefore, the patient remained hospitalized longer due to the clip was removed through a surgical-cutdown and the tissue damage was treated surgically.The first clip remains stable on the leaflets.One clip was implanted, and mr is 4.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated, and the reported torn soft tip appears to be due to procedural condition.There is no indication of a product issue with respect to manufacture, design or labeling.D9 - device available for eval updated from "yes" to "no".

• 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: 11499015
• MDR Text Key: 242175342
• Report Number: 2024168-2021-02074
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01116U417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER
• Patient Age: 81 YR
• Patient Weight: 121