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

Catalog Number SGC0101

Device Problems Loose or Intermittent Connection (1371); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The complaint device was returned for evaluation.The investigation indicated that the reported loose connection between the stopcock and luer was confirmed, and appears to be related to the observed cracks on the flush port threads; however, a definitive cause for the observed cracks could not be determined.Additionally, the reported irregular appearance could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This report is filed for the inability to connect the flush port to the stopcock.This could result in a leak during the procedure, which has the potential to cause or contribute to patient injury.It was reported that the stopcock would not stay connected to the flush port on the steerable guide catheter (sgc) during device preparation.There was no patient involvement.Another sgc was used with the same stopcock to complete the procedure without further incident.There was no clinically significant delay in the procedure.No additional information was provided.

• 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
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5445084
• MDR Text Key: 38748424
• Report Number: 2024168-2016-00960
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 51105U128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1