MAUDE Adverse Event Report: MEDTRONIC, INC. WHOLEY WIRE; WIRE, GUIDE, CATHETER

Catalog Number	WWIJ35145
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a wholey wire guidewire during patient treatment.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.It was reported the spring came off the wire which caused the wire to come apart in the catheter inside the patient.The spring was not released into the body as it was still in the catheter.The catheter and spring were safely removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis dimensional verification: the wholey guidewire system specimen presented an overall length of 144.8cm, and a finished diameter of.03335¿ to.03350¿.The wholey guidewire extension presented an overall length of 153.5cm and a finished diameter of.03355¿ to.03375¿.A gage bushing certified to be.0350¿ could not be passed over the length of the specimens because of the as received condition.Observation findings: the wholey guidewire system specimen presented bend damage at 127cm from the distal tip and an oversized sleeve interface gap of 0.2cm located from 99.2cm to 99.4cm.The wholey guidewire extension presented a ductile, tensile overload of extension wire at 0.6cm from the distal end.The specimen also presented bend damages at 0.7cm, 94cm and 144.5cm from the distal end.All joints appear to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appeared visually and dimensionally correct.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: WHOLEY WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19358173
• Report Number: 2182208-2024-02153
• Device Sequence Number: 6367877
• Product Code: DQX
• UDI-Device Identifier: 00763000185695
• UDI-Public: 00763000185695
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: WWIJ35145
• Device Lot Number: 8731589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown