MAUDE Adverse Event Report: MEDTRONIC, INC PROFLO 6F DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	010242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician used a pro-flo diagnostic catheter when crossing a valve.No damage was noted to packaging.The catheter was removed from packaging per ifu and inspected with no issues noted.The catheter was prepped per ifu with no issues.No resistance was encountered when advancing the catheter, no resistance used during insertion/ delivery.A clot was noted when they crossed the valve and hooked up to pressure.There was no other issues with coagulopathy (clotting) with this patient.An act was carried out.Results were 236 and 365.They noted a drop in pressure and pulled the catheter back where clot was noted.Patient was therapeutically heparinized.Patient is alive with no reported injury.
Additional Manufacturer Narrative
Product analysis: no visual defect noted to the catheter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROFLO 6F DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6727614
• Report Number: 1220452-2017-00067
• Device Sequence Number: 13764001
• Product Code: DQO
• UDI-Device Identifier: 20613994942801
• UDI-Public: 20613994942801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K960056
• 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): 08/11/2017

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: 05/08/2020
• Device Catalogue Number: 010242
• Device Lot Number: 51026817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 147