MAUDE Adverse Event Report: MEDTRONIC, INC PERSUADER 9 GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	9PROV300HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A pro via 9 guidewire was used during a procedure to treat a lesion in the superficial femoral artery.It is reported that the tip broke off the pro via 9 guide wire in vivo and the physician pinned the detached portion of the wire against the vessel wall with a stent.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: the wire exhibited two sharp kinks 61cm and 143cm from proximal end of the wire.The wire was received broken at the distal section of the dip, the break occurred 1.1cm from the first joint, the coil wire was also broken.The wire was severely twisted at the location of the break.The wire received is 298cm in total length.Approximately 2cm of the tip is missing.Actual wire outer diameter measurements, maximum at joints, along spring, coated core wire met specifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Two still images were received showing the detached tip stented against the vessel wall.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERSUADER 9 GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7270718
• Report Number: 1220452-2018-00019
• Device Sequence Number: 13954768
• Product Code: DQX
• UDI-Device Identifier: 20643169453030
• UDI-Public: 20643169453030
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100470
• 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,Followup
• Report Date (Section B): 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2018
• Device Catalogue Number: 9PROV300HS
• Device Lot Number: G15A08577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 07/17/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 06/13/2018; 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention