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

Catalog Number SGC0101

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed as during device preparation the hemostatic valve on the dilator of the steerable guide catheter was unable to tighten and a leak was noted.Although there was no patient involvement, if this were to recur in the anatomy, there is potential for air leak/ injury.It was reported that during device preparation the hemostatic valve on the steerable guide catheter dilator was unable to tighten.A leak was noted at the dilator hemostatic valve connection point.There was no patient involvement.The device was set aside for return.Another sgc and dilator were used without issue.There was no additional information provided.

Manufacturer Narrative

(b)(4).The complaint device was not returned, thus the reported leak could not be confirmed.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.A review of the complaint history identified no similar incidents for dilator leak.An expanded review was conducted that identified an issue potentially related to manufacturing.Further assessment of this issue per site operating procedures is being performed.The performance of these devices will continue to be monitored.

Manufacturer Narrative

(b)(4).

• 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: 5140632
• MDR Text Key: 28319023
• Report Number: 2024168-2015-05941
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 01/05/2016

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: 06/30/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50605U221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2015; 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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