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

Catalog Number	U5TRAP35SH
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
Date of Event	08/10/2017
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 was using a dexterity diagnostic catheter during a procedure.No damage was noted to the catheter packaging.The device was removed from packaging per ifu with no issues noted.The device was inspected and prepped per ifu.No resistance was encountered when advancing the device, excessive force was not used.The catheter was used in the proximal rca, which exhibited severe tortuosity and was not calcified.During use of the dexterity a spiral dissection of the rca occurred.There was no lesion in the location of the dissection.The patient was sent for bypass surgery as the physician was unable to get wire through the dissection to treat this ae.It is reported that patient is doing fine post procedure.
Additional Manufacturer Narrative
Cine image review: the reported dissection is confirmed, starting at the proximal rca and extending to the distal rca.Initial images identify a type b dissection and this developed into a type d dissection.This may have occurred due to a violent twist of the catheter during positioning or use.Due to the side holes facilitating blood passage when the artery/vessel ratio is 1:1, the position of the guide catheter and no observation of plaque during image review, the dexterity catheter catheter is not thought to have caused the dissection as a result of the location of the side holes.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: 6851351
• Report Number: 1220452-2017-00093
• Device Sequence Number: 13833688
• Product Code: DQO
• UDI-Device Identifier: 20643169738472
• UDI-Public: 20643169738472
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2018

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: 04/22/2020
• Device Catalogue Number: U5TRAP35SH
• Device Lot Number: 60057482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 02/23/2018
• 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
• Patient Age: 55 YR
• Patient Weight: 93