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

Catalog Number U5TRAP35SH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Intimal Dissection (1333); Patient Problem/Medical Problem (2688)

Event Date 08/10/2017

Event Type  Injury  

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 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.

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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6851351
• MDR Text Key: 85291737
• Report Number: 1220452-2017-00093
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20643169738472
• UDI-Public: 20643169738472
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Catalogue Number: U5TRAP35SH
• Device Lot Number: 60057482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 02/23/2018
• Date Device Manufactured: 04/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 93