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 09/02/2015

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 additional relevant information.

Event Description

This report is being filed for the inability to tighten the dilator cap and leak noted during device preparation.If this to recur in the anatomy there is potential for air leak/embolism.It was reported that during device preparation of the steerable guide catheter dilator, the tuohy valve would not tighten.While flushing, leaking was noted from the tuohy area.There was no device damage noted.The dilator was not used in the anatomy and there was no patient involvement.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the dilator was returned and the reported rotating hemostatic valve (rhv) leak and unstable dilator cap were confirmed.The dilator o-ring was observed to be misaligned with the flush port and the silicone seal was noted to be compressed and damaged.A search of the complaint handling database was performed and no other incidents were identified for leaks from this lot.A search of the lot history record for this specific lot indicated no related non-conformance records.Based on an expanded investigation, a product issue related to the observed leak and unstable dilator cap was noted.Further assessment of this issue per site operating procedures is being performed.Corrective and preventative actions are in the process of being implemented to address the issue per internal governing procedures.The performance of these devices will continue to be monitored.(b)(4).

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: 5099318
• MDR Text Key: 26723976
• Report Number: 2024168-2015-05551
• 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: Followup,Followup
• Report Date: 12/15/2015

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: 50608U202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/13/2015; 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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