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

Model Number H74939406XS1

Device Problems Bent (1059); Entrapment of Device (1212); Flaked (1246); Difficult to Remove (1528); Material Distortion (2977)

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

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturing batch lot was provided.A review the device history records for the guidewire involved in this incident revealed the product met specification prior to shipment.There was no indication of manufacturing defect or anomaly that could have impacted the event as reported.The device was not received for analysis; therefore no physical analysis of the product can be performed.The product is reportedly being returned for analysis but wasn't received by the time this report was submitted.Based on the information received to date an exact cause for the incident could not definitely be determined.If the product is returned for analysis or additional information is received a follow-up medwatch report will be submitted.Product hasn't been received.

Event Description

As reported; patient with calcified bicuspid valve.Physicians could not cross the annulus with the device.A few attempts were performed and decision was made to change the wire.During the removal of the device, the wire got stuck in the system.When force was applied, the nose cone detached from the device.The implanters made the decision not to continue the procedure and consider another way of treatment.

Manufacturer Narrative

This is a follow-up to the previous medwatch report.The manufacturing batch lot was provided.A review the device history records for the guidewire involved in this incident revealed the product met specification prior to shipment.There was no indication of manufacturing defect or anomaly that could have impacted the event as reported.The device was returned for analysis.As received, the specimen consisted of one each safari2 275 cm x sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The complaint of "the wire got stuck in the system" and "when force was applied the nosecone detached" was confirmed.The returned specimen presented ptfe coating damage scattered over the entire length of the specimen, a distorted preformed region with extensive offset/overlapping coil wrap damage.The specimen also presented multiple bends and offset/overlapping, stretched and cut coil damage located 52.85 to 127.65 cm from the proximal end with exposed core wire located 92.7 to 94.75 cm from the proximal end.The damaged lotus nosecone remained lodged on the wire shaft 94.75 to 97.15 cm from the proximal end.It was 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, device interface and clinical factors appear to have impacted on the event as reported.

• 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: 6386216
• MDR Text Key: 69329117
• Report Number: 2126666-2017-00025
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS1
• Device Lot Number: 10620675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 70