MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI2; WIRE GUIDE

Lot Number UNKNOWN

Device Problems Flaked (1246); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not received for analysis; therefore no physical or visual analysis of the product can be performed.The manufacturing batch lot was not provided therefore we were unable to review the device history records to confirm that the device met all material, assembly and inspection specifications prior to shipment.The device is not to be returned for analysis.If additional information is received or the product is returned for analysis a follow-up medwatch report will be submitted.No product returned.

Event Description

Friction while retracting catheter after releasing the valve.Wire stacked inside catheter.Procedure was completed with this device.

Manufacturer Narrative

The manufacturing batch lot was not provided therefore we were unable to review the device history records to confirm that the device met all material, assembly and inspection specifications prior to shipment.The device was received for analysis on 11/17/2016.As received, the specimen consists of one each clinically used, damaged, unknown safari wire; returned coiled, loose and double bagged within "zip-lock" style poly biohazard pouches.Due to the fact that the catheter was not returned with the guidewire the complaint could not be confirmed.The returned specimen presents several kinks/bends and several regions of offset coil damage scattered throughout the length of the device.Frayed/scraped ptfe coating is present adjacent to the kink/bend damage.The offset coil damage creates localized oversized diameters to.03865".The specimen also presents several stretched coil regions with the coil displacement in a proximal to distal orientation.Dimensionally, the specimen appears to be a best fit match to a safari2 275cm exsml crv wire.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.Based on the returned guidewire being identified as a possible best fit for a safari2 the 510k number was updated in this medwatch report.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• Type of Device: WIRE GUIDE
• 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: jackie ohnsorg ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418516
• MDR Report Key: 6072768
• MDR Text Key: 59056560
• Report Number: 2126666-2016-00089
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR