MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451504V5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two products involved with the reported event.The (b)(4).Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that there was a defect near two of the pigtail end of the tempo 5f uf 65cm 5sh catheter as the end started to break off.Six other devices were also returned that were damaged.There was no patient injury.
Additional Manufacturer Narrative
Additional information was received and the tempo catheter for this complaint did not crack in the patient; the device only kinked.Therefore, the complaint will be a non reportable case and no report will be needed.During use in patient, it was reported that there was a defect near two of the pigtail end of the tempo 5f uf 65cm 5sh catheter as the end started to break off.Additional information was received and the tips were kinked/bent' one of the catheter tip was hanging by a tiny piece.There was no patient injury.The event has happened in the aorta while directing the catheter.The device was prepped according to the instruction for use (ifu) there was no difficulty removing the product from the packaging.There were no damages to the device packaging.There was no excessive force used during the procedure.A non cordis catheter was used to complete the procedure.The device was removed from the patient in one piece.Six other devices were also returned that were kinked/bent.

• Brand Name: CATH TEMPO 5F UF 65CM 5SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7230530
• Report Number: 9616099-2018-01819
• Device Sequence Number: 1250374
• Product Code: DQO
• UDI-Device Identifier: 20705032008324
• UDI-Public: 20705032008324
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 02/29/2020
• Device Model Number: 451504V5
• Device Catalogue Number: 451504V5
• Device Lot Number: 17650755
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/02/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1