MAUDE Adverse Event Report: BAYLIS MEDICAL PROTRACK PIGTAIL WIRE; GUIDE WIRE

Catalog Number PTW-25-230

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

Reporter stated that the pigtail did not perform as it should.Physician said the pigtail advanced but did not loop as expected.No complications with pt.

• Brand Name: PROTRACK PIGTAIL WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): BAYLIS MEDICAL
• MDR Report Key: 7361162
• MDR Text Key: 103271292
• Report Number: MW5075973
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/26/2020
• Device Catalogue Number: PTW-25-230
• Device Lot Number: PWFA191217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR