MAUDE Adverse Event Report: CORDIS CORPORATION TEMPO 4 ANGIOGRAPHY CATHETER; DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)

Catalog Number 451457V0

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2014

Event Type  Injury  

Event Description

As reported, the tip of the rim catheter broke off in the patient.The doctor stented over the piece.The patient was not injured.

Manufacturer Narrative

The product will not be returned for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.Please note that the actual date of this event is unknown.The date provided event section: (b)(6) 2014 is incorrect and was provided for mdr (medwatch) acceptance purposes only.It is currently unknown if the initial reporter is a healthcare professional.

Manufacturer Narrative

The device is available to be returned for analysis; however, it has not yet been received.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The device has been received for analysis, and has been updated accordingly.The engineering report is not yet ready to be provided; however, it will be submitted within 30 days upon receipt.Additional information is pending.

Manufacturer Narrative

Method codes: visual inspection.Complaint conclusion: during treatment of the proximal right popliteal artery using a tempo catheter the tip of the ¿rim catheter broke off in the patient¿.The separated piece was stented.There was no patient injury and the patient is currently fine.The lesion was severely calcified with little tortuosity and angulation.The stenosis rate was (b)(6).The tempo catheter used for the procedure was not resterilized.There were no anomalies noted as the device was removed from the package or during prep.The device was not inserted through a stopcock instead of a hemostatic valve and there was no difficulty experienced or excessive torquing as the device was advanced to the lesion.The tip of the catheter separated during advancement to the lesion (proximal to the lesion).The device did not kink in the area of separation.After the separation, the tip migrated to the right anterior tibial artery.The tip was not retrieved.Instead, the patient was treated by stenting the tip in the patient.The patient is currently fine.The device was returned for analysis.One non sterile unit of cath tempo 4f rim 65cm was received coiled inside a plastic bag.On catheter body a kink condition was observed at 23.2 cm from distal tip.Tip was not observed on the catheter end, tip piece was not received for analysis.The catheter tip internal diameter (id) and outer diameter (od) were measured near to the separated area and it was found acceptable.Pull test was not performed as the unit received was not sterile.Catheter tempo was inspected under vision system and transfer of material was observed on the separated end.Separated distal portion looks elongated and evidence of distal tip remains can be observed on the intermediate tip (the separated distal tip piece was not included/ returned for analysis).No other anomalies observed.Sem analysis was required to determine the cause of the separation and the results showed that the body presented elongations and deformations induced by tension.The elongations observed presented evidence of plastic deformation as a product to which application of tension/force induced the separation.No other anomalies were found during sem analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The reported ¿brite tip/distal tip- separated-in patient" was confirmed through analysis of the returned device.The exact cause could not be conclusively determined.Based on the information available for review, factors contributing to the separation could not be determined.However, catheter body elongations and deformations noted during sem analysis may suggest that force was applied to the device resulting in separation.Neither the product analysis, nor the dhr suggest that the difficulty experienced by the customer could be related to the design or manufacturing process.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

Additional information was received: the intended procedure/ target lesion was treatment of the proximal right popliteal artery.The lesion was severely calcified with little tortuosity and angulation.The stenosis rate was (b)(6).The tempo catheter used for the procedure was not resterilized.There were no anomalies noted as the device was removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve and there was no difficulty experienced as the device was advanced to the lesion.Excessive torquing was not required.The tip of the catheter separated during advancement to the lesion.The device did not kink in the area of separation.The tip separation occurred when the device was proximal to the lesion.After the separation, the tip migrated to the right anterior tibial artery.The tip was not retrieved.Instead the patient was treated by stenting the tip in the patient.Another catheter was not used to complete the procedure.There was no patient injury and the patient is currently fine.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

• Brand Name: TEMPO 4 ANGIOGRAPHY CATHETER
• Type of Device: DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4361126
• MDR Text Key: 5118830
• Report Number: 9616099-2014-00825
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 451457V0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention; Disability