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 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report that during preparation of the steerable guiding catheter (sgc), the hemostasis valve of the dilator was leaking.If this were to reoccur in the anatomy, a leak has the potential compromise the fluid path integrity and lead to an air embolism.It was reported that during preparation of the steerable guiding catheter (sgc), the hemostatic valve would not close and was leaking.The valve was loosened and re-tightened as much as possible but the valve was still leaking.The decision was made to replace the device.The device was not used in the anatomy and there was no patient involvement.No additional information was provided.

Manufacturer Narrative

(b)(4).As the device was not returned for evaluation, a failure analysis of the complaint device could not be performed.The analysis of this complaint was an assessment of the manufacturing records and information provided to abbott vascular.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.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.

• 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: 5258630
• MDR Text Key: 32530971
• Report Number: 2024168-2015-07183
• 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,Followup
• Report Date: 12/16/2015

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: 07/31/2016
• Device Catalogue Number: SGC0101
• Device Lot Number: 50714U123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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