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

Catalog Number SGC0301

Device Problems Leak/Splash (1354); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) leak.It was reported that during preparation of the sgc, it failed to hold column during preparation [leak].It was noticed at the distal end of the shaft some glue was missing.Air was entering the guide coming up from handle towards valve.The sgc was not used and another sgc was used successfully in the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned.The results of the returned device analysis confirmed the reported steerable guide catheter (sgc) leak and indicated that a hole on one of the lumens at the skive resulted in the leak.The reported irregular appearance/physical property issue was not confirmed, as the glue fillet was sufficiently present around the circumference of the hypotube at the distal end.A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have contributed to this reported event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, the irregular appearance appears to be related to the user perception.The reported leak appears to be related to the observed hole on one of the lumens at the skive.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• 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: 7496492
• MDR Text Key: 107716905
• Report Number: 2024168-2018-03393
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 71212U217
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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