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

Catalog Number SGC0301

Device Problems Break (1069); Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The 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 steerable guide catheter cable break.It was reported that during use of the steerable guiding catheter (sgc), extreme curves were applied on the sgc, due to the tortuous anatomy.The +/- knob was turned in the + direction, approximately 360 degrees and the tip of the device no longer responded/unable to curve.A cable break occurred.The same sgc was continued to be used with the mitraclip delivery system (cds) to complete the procedure.A total of two clips were implanted, reducing mixed mitral regurgitation from 4 to <1.There was no reported adverse patient effect or a clinically significant delay in the procedure.The patient remained stable.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: the device was returned for analysis.The reported cable break and mechanical issue were 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 similar incidents reported from this lot.It should be noted that the instructions for use (ifu) states: excessive torque on the guide and translation of mitraclip nt system may inadvertently displace the tip of the guide from left atrium (la).The user error likely did not contribute to any of the reported issues.Based on the information reviewed the reported cable break was due to user technique and patient pathology/morphology.The mechanical issue of unable to curve the device was a cascading effect (procedural circumstances).There is no indication of product quality issue with respect to manufacture, design or labeling.

• 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: 8446465
• MDR Text Key: 139713266
• Report Number: 2024168-2019-02272
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90103U157
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP DELIVERY SYSTEM
• Patient Age: 90 YR
• Patient Weight: 90