MAUDE Adverse Event Report: MEDTRONIC, INC GUARDWIRE TEMPORARY OCCLUSION SYSTEM; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

Catalog Number	GEZ6200US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: severe signs of torque were noted at the distal bond taper and at the broken pet tubing, subsequently breaking the hypo tube coiled section approximately 1.5cm from the proximal taper.Due to this break, the core wire pulled out of the proximal hypo tube, resulting in the broken tip to remain inside the patient as reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a guardwire device in a distal saphenous vein graft (svg) which exhibited moderate tortuosity, severe calcification and 90% stenosis.The guardwire was removed from packaging per ifu.The device was inspected and appeared intact.The device was prepped per ifu.Resistance was encountered when trying to cross the lesion, while torquing the balloon broke and then detached from the wire when attempting to remove the balloon through a 6fr sheath.It was successfully retrieved utilizing a snare.The balloon had not been inflated.The physician was trying to advance wire through a calcified lesion.No patient injury reported.
Additional Manufacturer Narrative
Correction to product analysis text: the detached tip was retrieved successfully from the patient using a snare.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: GUARDWIRE TEMPORARY OCCLUSION SYSTEM
• Common Device Name: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6587480
• Report Number: 1220452-2017-00048
• Device Sequence Number: 11046336
• Product Code: NFA
• UDI-Device Identifier: 10721902644167
• UDI-Public: 10721902644167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023878
• 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): 05/24/2017

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: 05/12/2017
• Device Catalogue Number: GEZ6200US
• Device Lot Number: 0008053205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided; 05/24/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/22/2017; 10/04/2017
• 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
• Patient Age: 71 YR