MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; UROLOGICAL CATHETER AND ACCESSORIES

Model Number M006630222B0

Device Problem Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

The device was not received for evaluation; therefore no physical analysis of the device can be performed.The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications.It was reported that the patient is okay without any problems.Reviewing all details received to date, it appears clinical and or procedural factors may have impacted on the reported event.It was reported that the device is not expected to be returned; however, if there is any further relevant information provided, a follow-up report will be submitted.

Event Description

Per email: event during surgery: perforation in the left kidney during surgery.Additional information: how was the perforation resolved? doesn't need to be resolved.Very small.What were the interventions/treatments given to the patient for the bleeding? none.It has stop at the end.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Type of Device: UROLOGICAL CATHETER AND ACCESSORIES
• 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: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 5430614
• MDR Text Key: 38015120
• Report Number: 2126666-2016-00009
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: M006630222B0
• Device Catalogue Number: M006630222B0
• Device Lot Number: 10607826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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 Outcome(s): Other