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

Catalog Number SGC0301

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed for cable break.It was reported that the patient, with degenerative mitral regurgitation (mr), underwent a mitraclip procedure, treating mr of grade 4.Patient anatomy included a posterior prolapse.The steerable guide catheter (sgc) was prepared for use and no issues were noted.Prior to advancement into the patient anatomy, the physician attempted to straighten the sgc, but was overly aggressive with the minus knob and the cable broke.The device was not used and there was no patient injury.A second sgc was prepared for use and advanced into the patient anatomy without issue.The clip delivery system (cds) was advanced and positioned to grasp the leaflets; however, the physician was never able to grasp both leaflets due to the patient anatomy.The device was removed without patient injury.The decision was made to abort the procedure and wait until the site received the xtr clip delivery system.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned and investigated.The reported cable break was confirmed.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 quality issue.Mitraclip instructions for use (ifu) states to rotate the plus minus knob in the minus direction until the guide curve is substantially straightened.All available information was investigation and the reported improper or incorrect procedure or method appears to be due to use error as the steerable guide catheter (sgc) knob was aggressively rotated before entering the device into patient anatomy and the reported cable break appears to be a cascading effect of the use error.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture 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: 7744438
• MDR Text Key: 115908324
• Report Number: 2024168-2018-05996
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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: 08/07/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 70804U236
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 70