MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012817-16

Device Problems Leak/Splash (1354); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported leak was confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Based on visual and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

A perforation occurred and the graftmaster, using a radial access site, was advanced but failed to cross.The lesion was dilated and the graftmaster was advanced towards the lesion but failed to cross again.The graftmaster was removed out of the anatomy when blood was observed to be coming into the lumen.In an attempt to examine the device, the graftmaster catheter was pressurized outside the anatomy and pressure could not be applied properly.The graftmaster catheter was not used any further for the procedure.The perforation caused by a balloon catheter recuperated [sealed] by itself, and the procedure was stopped.There was no clinically significant delay in the procedure.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: sionblue; guide cath: heartrail 6fr il4,opticross.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4398231
• MDR Text Key: 12898192
• Report Number: 2024168-2015-00125
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 1012817-16
• Device Lot Number: 4100342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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