MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: guide catheter: 6f jl4; stent: 3.5 x 12 mm xience xpedition.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The xience xpedition referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a lesion in the mildly tortuous, heavily calcified mid left anterior (lad) coronary artery.A balance middleweight (bmw) guide wire was advanced to the lesion and crossed.A non-abbott cutting balloon catheter was advanced to the lesion with some difficulty and after use was removed from the anatomy with no issues noted.A 3.50 x 12 mm xience xpedition stent delivery system (sds) was advanced over the bmw guide wire in the non-abbott 6f guiding catheter (gc) and near the distal end of the gc the sds met resistance and would not advance any further on the bmw guide wire.The sds could not be retracted over the bmw guide wire, therefore the sds, bmw guide wire and gc were removed from the anatomy as one unit.It was suspected that bmw guide wire may have been damaged and the sds became stuck on it.A new unspecified guiding catheter, unspecified guide wire and another 3.5 x 12 mm xpedition sds were used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Unique device identifier (udi): in the absence of reported part and lot#, udi can not be provided.The device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The difficult to position and remove the sds were confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6113623
• MDR Text Key: 60746706
• Report Number: 2024168-2016-08110
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K013833
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES