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

Catalog Number 1001780S-HC

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: 3.5x15 alpine.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other devices referenced are being filed under separate medwatch reports.

Event Description

It was reported that during the procedure to treat a target lesion in the proximal right coronary artery, the balance middleweight (bmw) guide wire was advanced and the 3.5 x 15 mm xience alpine stent delivery system was advanced over the guide wire; however, resistance was felt.The stent delivery could not be removed from the guide wire and both devices were removed from the patient anatomy as a single unit.The second 3.5 x 15 mm xience alpine stent delivery system was advanced and resistance was also felt during advancement of this device.The second xience alpine could not be removed from the guide wire and both devices were removed from the patient anatomy as a single unit.There was no adverse patient effect and no clinically significant delay.The procedure was completed using a new guide wire and implantation of three stents.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis with foreign material on the guide wire coils.Visual, dimensional, and functional inspections were performed on the returned device.The difficult to position and remove were confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the foreign material on the guide wire coils resulted in resistance during advancement and retraction of the stent delivery system (sds).A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4).

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• 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: 6210146
• MDR Text Key: 63710325
• Report Number: 2024168-2016-09291
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1001780S-HC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 78 YR