MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY TRA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	U5TRAN45SHA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 used a dxterity guide catheter when treating the rca (ostium/ proximal/ mid).No damage was noted to the packaging of the catheter.The catheter was removed from packaging per ifu and inspected with no issues noted.The catheter was prepped with no issues noted.No resistance was encountered when advancing the gc, excessive force was not used.The rca had no calcification, no tortuosity.When the physician went to engage the catheter, a spiral dissection occurred in the ostium to mid vessel , caused by the diagnostic catheter when it engaged the slightly anterior take off of the rca.The dissection was treated with two drug-eluting stents.No specific malfunction reported but the physician said the stiffness of the tip of the dxterity is more than likely the cause.There is no alleged product issue.No additional patient clinical sequelae reported.
Additional Manufacturer Narrative
Cine image review: review of the still images provided confirm the occurrence of a spiral dissection in the vessel, firstly, the lv gram is taken using a right coronary catheter, rather than a pigtail, causing a run of vt.The rca is not normal on the first angio.There is a lesion or fold at about 3cm distal to the ostium.The next image shows occlusion at this point.On review of the images it cannot be confirmed if there is an ostial dissection caused by the device, or whether the vessel occluded at the lesion point.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: DXTERITY TRA
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6621801
• Report Number: 1220452-2017-00053
• Device Sequence Number: 16162836
• Product Code: DQO
• UDI-Device Identifier: 20643169738953
• UDI-Public: 20643169738953
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161287
• 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): 06/27/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2020
• Device Catalogue Number: U5TRAN45SHA
• Device Lot Number: 60041488
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 06/27/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/27/2017; 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: 57 YR
• Patient Weight: 70