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

Catalog Number	008944
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the wire was received in the hoop and exhibited a kink to the wire.The wire was pulled out of the hoop, a severe kink was noted in the mid-section of the wire.The wire appeared wavy.Coils as received exhibited some separation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 0.035" angiographic wire was used in a procedure to treat a non-tortuous, non-calcified lesion with 10% stenosis in the mid lad.There was no damage noted to the device packaging.There were no issues when removing the device from the packaging per ifu.The device was prepped per ifu with no issues.The wire tip was not formed by the physician.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It is reported that the distal wire tip was very sharp and was scraping through the catheter.No patient injury is reported.
Additional Manufacturer Narrative
Additional product analysis: coating on the wire was visually inspected and found to conform to all visual acceptance criteria.Tip appears rounded and smooth with no sharp edges, burrs, etc.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: 7654161
• Report Number: 1220452-2018-00082
• Device Sequence Number: 16174490
• Product Code: DQX
• UDI-Device Identifier: 20643169857180
• UDI-Public: 20643169857180
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: 10/28/2022
• Device Catalogue Number: 008944
• Device Lot Number: GFBX0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1