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

Catalog Number SGC0302

Device Problems Detachment Of Device Component (1104); Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The steerable guide catheter 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 is filed to report that the rotating hemostasis valve (rhv) was loose.It was reported that after the steerable guide catheter (sgc) and dilator were removed from the package, the preparation was started by attempting to close the rotating hemostasis valve (rhv) cap; however, the cap felt loose and then fell off when touched.It was not possible to replace the rhv cap on the dilator so a new device was opened.No portion of the mitraclip system was used in the anatomy and there was no clinically significant delay in the procedure.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).Evaluation summary: the clip delivery system was returned and investigated.The reported dilator cap detachment was confirmed; however, the instability of the cap was not confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the instability and detachment of the dilator cap were related to improper user technique.The returned device analysis confirmed that the cap functioned as expected once it was pressed back onto the rotating hemostatic valve (rhv).Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 6695682
• MDR Text Key: 79507144
• Report Number: 2024168-2017-05720
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K161985
• 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: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2018
• Device Catalogue Number: SGC0302
• Device Lot Number: 70307U122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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