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

Catalog Number SGC01ST

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the dilator and rotating hemostasis valve (rhv) cap were returned.The teflon o-ring was not returned in the rhv or in the packaging tray.The reported dilator cap detachment was confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a definitive cause for the reported detachment of the dilator cap in this incident could not be determined.The returned device analysis confirmed that the cap functioned as expected once it was pressed back onto the rhv.In this case, it is possible that the user technique of opening the rhv cap contributed to the reported cap detachment and subsequent o-ring detachment; however, this cannot be definitively confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

Event Description

This is filed because returned device analysis found that the teflon o-ring was not observed in the rotating hemostatic valve (rhv); if a device with missing o-ring were used in the anatomy, there is potential for air leak.It was reported that, during preparation of the steerable guiding catheter (sgc), when attempting to close the rotating hemostatic valve for flushing, the dilator cap detached from the dilator and could not be reinstalled.There was no patient involvement with the dilator and no clinically significant delay in the intended procedure.No additional information was provided regarding the sgc issue.Subsequently, returned device analysis revealed the teflon o-ring was separated from the dilator rotating hemostatic valve (rhv).

• 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: 5914815
• MDR Text Key: 54192168
• Report Number: 2024168-2016-05811
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648149559
• UDI-Public: (01)08717648149559(17)170331(10)60314U115
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60314U115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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