MAUDE Adverse Event Report: LAKE REGION MEDICAL WALLSTENT SUPER STIFF GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number H965180011

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Reportable based on the device analysis.A review of the device history record of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and was determined to be acceptable.The complaint of damage is confirmed.The specimen outer coil wire has been severed at 203.3cm and 337.3cm from the distal tip; the severed ends of the coil wire present shear fractures and the underlying core wire presents collateral witness impressions from the cutting edge.The ptfe coating in the vicinity of the severed coil regions is scraped and frayed with loose ptfe easily removed by the gage bushing.The specimen also presents several bends of varying severity and frequency scattered over the length of the device.No other damage or inconsistencies are noted to the specimen at this time.The core wire is intact.All joints appear to be correct and intact by visual examination and by non-destructive testing.Based on the evidence presented by the sample and the information provided by the supporting documentation it appears that procedural factors have impacted on the event as reported.

Event Description

Could not place the stent over the wire because the blue jacket of the wire was damaged.

• Brand Name: WALLSTENT SUPER STIFF GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 5053136
• MDR Text Key: 24911605
• Report Number: 2126666-2015-00053
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K760944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: H965180011
• Device Catalogue Number: 18001
• Device Lot Number: 10380737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• 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
• Patient Age: 60 YR