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

Catalog Number SGC01ST

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

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 since the rotating hemostatic valve was loosely attached to the dilator and then separated.It was reported that upon inspecting the dilator, the rotating hemostatic valve (rhv) was loose.The rhv cap was being tightened per instructions for use (ifu) when the entire rhv separated from the dilator.The cap was also reported as separated.The device was set aside and another device was used in replacement.There was no patient involvement.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and all available information was investigated and the reported dilator cap detachment was 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.Based on the information reviewed, the detachment of the dilator cap was 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).There is no indication of a product quality issue with respect to manufacture, design or labeling.Based on information received after the initial mdr was submitted, that the rhv cap separated not the rhv itself, this event would not be mdr reportable.

Event Description

Subsequent to the initial medwatch report filed, additional and corrected information received: the rhv itself did not separate nor was it unstable from the dilator.The rhv cap separated after being closed during the preparation.

• 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: 6662348
• MDR Text Key: 78381857
• Report Number: 2024168-2017-05294
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60824U130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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