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

Catalog Number	010242
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombus (2101)
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use a proflo diagnostic catheter during a procedure.The catheter was flushed.It is reported that clots formed within the catheter only, when the proflo catheter was in the patient.The device was not flushed during use due to the presence of thrombus.No intervention was carried out.No adverse event was caused to the patient as a result.
Additional Manufacturer Narrative
Catheters are routinely flushed upon removal from packaging and flushed upon insertion with standard concentration of heparin.Evaluation summary: received for analysis was one 6f proflo pigtail catheter coil wrapped in bio bag with original packaging.As received the catheter is bloody but un-damaged.The catheter was flushed into a clear beaker using a syringe and water.No clots present from initial flush.The water came out through the side holes without issue indicating no blockage from the sideholes to the proximal hub.The side holes we blocked with fingers and a little pressure applied to syringe.The catheter was flushed into clear beaker and clots came from the tip.The beaker was poured through a strainer.Clot approximately 1.75 cm in length was present.The analysis confirmed clots in the distal tip of the catheter.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.
Additional Manufacturer Narrative
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: 6184830
• Report Number: 1220452-2016-00081
• Device Sequence Number: 730489
• 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,Followup
• Report Date (Section B): 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: 010242
• Device Lot Number: 51013134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided; 01/13/2017
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/10/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1