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

Model Number	007447
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 0.035 x 145cm ptfe guide wire was used during a procedure to treat a non tortuous, non calcified lesion.It was reported that the outer core of the wire separated from the inner core of the wire.The patient is alive with no injury.Their was no impact to the patient and their current status is good.Sr (b)(4) was created for the comment "it has occurred on/during several procedures.".
Additional Manufacturer Narrative
Additional information: no damage was noted to packaging.No issues were noted to the device when removing from the packaging per ifu.The device was inspected.The device was prepped per ifu.The wire tip was not formed by the physician.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during insertion/delivery.It was not possible to advance the device over the aortic arch.Device evaluation: one 0.035¿ moveable core guidewire was received for analysis.The inner moveable core wire was partially removed approx.2cm from the spring.No deformation was noted to the wire.Visual inspection carried out noted the guidewire appeared longer in length because the moveable core wire had been partially removed from the spring at some point (approx.2.7cm).The core wire has a smaller od than the spring as per specification.Id, od, length and the gap between the handle (moveable core wire) and the spring guide were measured, and all met specification.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANGIOGRAPHIC GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9620048
• Report Number: 1220452-2020-00008
• Device Sequence Number: 11287810
• Product Code: DQX
• UDI-Device Identifier: 00643169856844
• UDI-Public: 00643169856844
• Combination Product (Y/N): N
• Initial Reporter Country: UG
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2020

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 Expiration Date: 01/28/2024
• Device Model Number: 007447
• Device Catalogue Number: 007447
• Device Lot Number: GFDN0680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 03/06/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 04/03/2020; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1