MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR

Model Number SGC0301

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other device mentioned will be filed under a separate medwatch report.

Event Description

This is being filed to report the torn tip. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was successfully implanted. A second clip delivery system (cds) was advanced to the mitral valve however the mr was unable to be reduced further. The leaflets were ungrasped and the clip repositioned several times however the mr was unable to be reduced. The cds was retracted per the instructions for use (ifu) however the clip became caught on the tip of the steerable guide catheter (sgc). Standard troubleshooting was performed; however the clip could still not be retracted. The system was pulled back to the right side and pulled through the septum without issue. It was noted the clip looked like it had detached from the mandrel even though no deployment had been initiated. The sgc and cds were retracted to the groin where it was noted one clip arm was inside the sgc and one clip arm was stuck on the vessel wall. A vascular surgeon was called to perform a cut down. Once removed, it was confirmed the clip was no longer attached to the mandrel but was still attached to the cds by the lock and gripper lines. The procedure was completed at this time with the mr reduced to 3. There was no clinically significant delay in the procedure and no adverse patient sequela. Return analysis noted the tip of the sgc was torn. No additional information was provided.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 9921295
• MDR Text Key: 186367400
• Report Number: 2024168-2020-03337
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/21/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91122U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• 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: 04/03/2020 Patient Sequence Number: 1

Treatment

1 IMPLANTED MITRACLIP