MAUDE Adverse Event Report: LAKE REGION MEDICAL SCHNEIDER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number H965SCH380250

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

Reportable based on the product analysis completed on 17 february 2015.It was reported the schneider guidewire did not straighten correctly and it was difficult to insert.However, the returned product analysis revealed that the ptfe coating was scraped in multiple locations.

Manufacturer Narrative

(b)(4).As received, the specimen presents an overall length of 151.60cm and a finished diameter of.03415" to.03425".A gage bushing certified to be.0355" was passed over the length of the device.The specimen presents numerous bends and offset coil damage over the distal 7.0cm and scattered bends and scraped ptfe coating over the length of the device.The specimen presents scraped ptfe coating located 51.0 to 57.5cm and 112.0 to 116.0cm from the distal tip, with a 3mm stretched coil segment 31.0 to 31.3cm from the distal tip.The specimen also presents dried deposits of blood-like material and other biomaterial deposits on and between the coil wraps and within the coil lumen throughout the length of the device, consistent with clinical use.No other damage or inconsistencies are noted to the specimen at this time.All joints appear to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appears visually and dimensionally correct.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• Brand Name: SCHNEIDER 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4610055
• MDR Text Key: 21724614
• Report Number: 2134265-2015-01292
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K760944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: H965SCH380250
• Device Catalogue Number: SCH-38025S
• Device Lot Number: 0010307028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2013
• 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: 67 YR
• Patient Weight: 70