MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F BER II 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451515H0

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: 5f tempo ber 100cm catheter.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 Description

As reported, a quantity of three 5f tempo ber ii 100cm diagnostic catheters were being used for a thoracic endovascular aneurysm repair (tevar), the first catheter was found to be leaking when being flushed and the other two broke when being put on the wire.There was no reported patient injury.The second and third catheters were not used inside the patient.A new catheter was used to complete the procedure.At the time all of the catheters were in date, a few were about to expire.Another cordis 5f tempo ber 100cm catheter was used to complete the procedure.No anomalies were noted when the first device was removed from the packaging.The first device was not resterilized.The first device was flushed with heparinized saline for the insertion of the guidewire.Upon flushing the first device, it was noticed that there was a clean break mid-shaft of the catheter.The second device was removed from the packaging and was flexed to make sure it was strong, it snapped in four places.No further anomalies were noted during prep of the second device.The second device was discarded.The third device was removed from the packaging and was flexed to make sure it was strong, it snapped in four places.No further anomalies were noted during prep of the third device.The third device was discarded.

Manufacturer Narrative

Complaint conclusion: three 5f tempo ber ii 100cm diagnostic catheters were being used for a thoracic endovascular aneurysm repair (tevar), the first catheter was found to be leaking when being flushed and the other two broke when being put on the wire.There was no reported patient injury.A new catheter was used to complete the procedure.At the time all the catheters were in date, a few were about to expire.Another cordis 5f tempo ber 100cm catheter was used to complete the procedure.No anomalies were noted when the first device was removed from the packaging.The first device was not resterilized.The first device was flushed with heparinized saline for the insertion of the guidewire.Upon flushing the first device, it was noticed that there was a clean break mid-shaft of the catheter.The second device was removed from the packaging and was flexed to make sure it was strong, it snapped in four places.No further anomalies were noted during during prep of the second device.The third device was removed from the packaging and was flexed to make sure it was strong, it snapped in four places.No further anomalies were noted during during prep of the third device.No other information was reported.The devices were not returned for analysis.2019-00062083-1 a product history record (phr) review of lot 17501765 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿catheter (body/shaft) cracked - during prep¿ could not be confirmed and the devices were not returned for analysis.Storage and handling factors may have contributed to the reported events.According to the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ neither the phr reviews nor the event description suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH TEMPO 5F BER II 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8448035
• MDR Text Key: 139703249
• Report Number: 9616099-2019-02803
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032008478
• UDI-Public: 20705032008478
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 451515H0
• Device Catalogue Number: 451515H0
• Device Lot Number: 17501765
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1