MAUDE Adverse Event Report: LAKE REGION MEDICAL THRUWAY GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number M001492971

Device Problems Bent (1059); Entrapment of Device (1212); Flaked (1246); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation at the time of this report; therefore no physical analysis of the device can be performed.The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

Note: this report pertains to the first of two wire devices used during the procedure.Medwatch report 2126666-2018-00002 captures the second device.The wires/balloons were not able to be advanced/withdrawn in the body and both were required to be withdrawn without inflation.No harm was done to the patient.No information about the patient was given.The procedure was completed with another wire and catheter.

Manufacturer Narrative

Device evaluation: the batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.As received, the specimen consists of one 300-014 gw, short taper; returned firmly lodged within the balloon catheter, coiled, loose within "zip-lock" style poly biohazard pouches.The distal 56.3cm of the thruway wire is extending from the distal tip of the balloon catheter.The specimen wire presents numerous bends/kinks of varying severity and frequency scattered over the length of the wire.The exposed ptfe coated wire shaft present several areas of scraped coating with coating removal to either aspect of the balloon catheter.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, clinical and/or procedural factors appear to have impacted on the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• 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: 7227187
• MDR Text Key: 98852649
• Report Number: 2126666-2018-00001
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042338
• 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: 02/07/2018

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 Model Number: M001492971
• Device Catalogue Number: 49-297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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