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 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guide catheter 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 leak observed during preparation.A leak has potential to cause or contribute to air embolism if the device were to be used in the patient.It was reported that during preparation of the steerable guiding catheter (sgc), the dilator was flushed but a leak was observed at the rotating hemostatic valve, as the cap would not close tightly.The decision was made to replace the device.There was no patient involvement.A new dilator was used without issue.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The steerable guiding catheter (sgc) was returned and device analysis confirmed the reported issue of a leak at the dilator rotating hemostasis valve (rhv) and unstable dilator cap.The dilator o-ring and silicone seal were misaligned and the silicone seal was noted to be compressed.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 procedures.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: 5079434
• MDR Text Key: 26168388
• Report Number: 2024168-2015-05366
• 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: 50608U116
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2015; 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