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

Catalog Number	007042
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
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
Two angiographic 0.035" wires were intended to be used during a procedure.Only one device was used in the patient.During the procedure, a femoral approach was used to access the ostium of the rca.There was no damage noted to the packaging.There were no issues noted to the devices when removing from the packaging per ifu.Both wires were inspected and prepped per ifu without issues.The wire tips were not formed by the physician.Poor steerability was noted.It was also noted during removal of the device used in the patient, that the coils were separated and the wire was kinked.The second wire was tested outside the patient and kinked.Patient alive with no injury.
Additional Manufacturer Narrative
Product analysis: the wire appears used, bloody kinked approx.2cm from tip.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: 7577193
• Report Number: 1220452-2018-00069
• Device Sequence Number: 1524493
• Product Code: DQX
• UDI-Device Identifier: 00643169856714
• UDI-Public: 00643169856714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 007042
• Device Lot Number: GFCQ2386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 81