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

Catalog Number SGC01ST

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This event is being filed because the steerable guide catheter (sgc) was returned with the hemostasis valve bond broken, which has the potential to cause leaks, and leaks have the potential to cause or contribute to adverse patient effects.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The clip delivery system (cds) could not be advanced into the steerable guide catheter (sgc); thus the sgc was removed without reported issue.The same cds and a new sgc were used to successfully complete the procedure, with mr reduced to <1, with no patient effects, and no clinically significant delay in the procedure.There was no additional information provided.The sgc was returned with the hemostasis valve bond broken.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis, which identified a broken bond between the hemostatic valve (hv)and the steerable guide catheter shaft.A review of the lot history record was conducted and found no exceptions associated with this lot during manufacturing.A review of the complaint handling database was performed and identified no complaints for loose hv from this lot.An expanded review was conducted that identified an issue potentially related to manufacturing.Further assessment of this issue per site operating procedures is being performed.The performance of these devices will continue to be monitored.

• 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: 5068320
• MDR Text Key: 26032552
• Report Number: 2024168-2015-05257
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• 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
• Report Date: 09/29/2015

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: 03/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50304U207
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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