MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem Perforation (2001)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the torn soft tip, perforation and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced into the femoral vein, but resistance was felt.Force was applied, but the sgc tip became bent and torn.The sgc was removed to be replaced; however, bleeding was observed at the puncture site.An unspecified covered stent was deployed to treat the perforation.The procedure was continued.One clip was implanted, reducing mr to 1-2.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1316 labeled.Internal file number - (b)(4).Correction: device code 1467 removed replaced with 1316.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the definitive cause for the reported difficult to insert that resulted in torn steerable guide catheter (sgc) soft tip and perforation couldn't be determined.It should be noted that the instructions for use (ifu) states, do not use excessive force to advance or manipulate the guide-dilator assembly.It appears that the user error did contribute to the reported tear in sgc soft tip and perforation.Additionally, the reported patient effect of perforation is listed in the ifu as a known possible complication associated with mitraclip procedure.There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8627761
• MDR Text Key: 145638478
• Report Number: 2024168-2019-03962
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90216U157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention