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

Model Number H74939272S0

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records of the specimen device lot 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 at lake region medical and was determined to be acceptable.The safari guidewire was received for analysis.As received, the specimen consisted of one each clinically used, damaged safari wire 300cm sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented numerous offset/mis-aligned/overlapping coil wraps resulting in localized oversized diameters with scraped ptfe coating and coating removal in the overlapping coil region at approximately 14.9cm from the proximal end and at the outside surface of the bend damage.The specimen also presented several bends of varying severity.The coating removal appears consistent with the coil wire rubbing on the inner lumen wall surface of the catheter.Deposits of dried blood-like material are present on and between the coil wraps.There is no indication of the device becoming "decoiled." 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 contributed to the event as reported.

Event Description

After system withdrawal the guidewire proximal portion got stuck inside the system catheter, physician experienced high resistance to retrieve the wire.After several attempts the wire was finally removed, further inspection showed a small portion of the wire getting decoiled.Valve implantation was completed normally with this device, patient condition is stable.

• Brand Name: PREFORM GUIDEWIRE - SAFARI
• 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: 5934861
• MDR Text Key: 54150078
• Report Number: 2126666-2016-00080
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/07/2016

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 Expiration Date: 01/31/2019
• Device Model Number: H74939272S0
• Device Catalogue Number: 39272S0
• Device Lot Number: 10634443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR