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

Model Number H74939272L1

Device Problems Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Material Distortion (2977)

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

Event Date 08/11/2015

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 record review confirmed that the device met all material, assembly and inspection specifications.The product is expected to be returned.If the product is returned or additional information is received a follow-up medwatch report will be submitted.Product is expected to be returned.

Event Description

For a sapien implant size 26 the safari wire was used as they normally do.When inserting the system it got stuck on the safari wire.They couldn't get the system over the wire.Device was taken out and safari wire too.When inspecting the wire they found a spot where the wire was thicker than normal.

Manufacturer Narrative

A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The returned specimen presents offset/overlapping coil wraps located 125.25 to 125.4cm from the distal tip with damaged ptfe coating at the offset coil damage, and a large radius bend over the proximal 23cm.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.Based on the evidence presented by the sample and the information provided by the supporting documentation it appears that procedural and/or clinical factors may have impacted on the event as reported.

• 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: 5092042
• MDR Text Key: 26485834
• Report Number: 2126666-2015-00061
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Report Date: 10/15/2015

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: Physician
• Device Expiration Date: 11/28/2017
• Device Model Number: H74939272L1
• Device Catalogue Number: 39272L
• Device Lot Number: 10472179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• 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: 82 YR