MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY

Catalog Number	U6ULTRA40SHA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/21/2019
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
During a procedure an attempt was made to use a dxterity diagnostic angiography catheter to treat a mildly tortuous, mildly calcified lesion exhibiting 100% chronic total occlusion in the right coronary artery (rca).There was no damage noted to the packaging.The device was removed from packaging as per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that a dissection occurred during the procedure.It was indicated that the curve of the device may have contributed to this event.
Additional Manufacturer Narrative
The patient was transferred for surgical intervention.It was stated that the medical staff were not aware of any relevant patient medical history that may have made them more prone to a dissection.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DXTERITY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8835192
• Report Number: 1220452-2019-00091
• Device Sequence Number: 16790974
• Product Code: DQO
• UDI-Device Identifier: 00763000016791
• UDI-Public: 00763000016791
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 08/22/2019

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: 04/23/2022
• Device Catalogue Number: U6ULTRA40SHA
• Device Lot Number: 60180501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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: Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 102