MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F C2 65CM 2SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451443V2

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

This event is related to 9616099-2019-03018 and was previously reported under 9616099-2019-03019 and 9616099-2019-03020; however, based on the two devices returned for evaluation, neither device corresponds to the product reported under 9616099-2019-03019 and 9616099-2019-03020.Two non- sterile units of product ¿cath tempo 4f c2 65cm 2sh¿ were received coiled inside a plastic bag.Catheters were unpacked to be visually inspected.A body separation condition was observed located at 62.5 cm from the hub.The separated section was not returned for analysis.No other damages or anomalies at the part were detected.Separated section was evaluated with the vision system observing that the edges present evidence of elongations, frayed condition and twisted characteristics.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the separation.No other anomalies were observed during analysis.Dimensional analysis was performed to verify the correct catheter id and od.Measurements were taken close to the separation area at 60 cm from the hub.Dimensional analysis results were found within specification.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, two tempo catheters (cath tempo 4f c2 65cm 2sh) became separated while being used with a non-cordis liver and biopsy set.The separated segments migrated to the lung arteries and were snared/retrieved using two unknown device.The devices were clinically used and will be returned for analysis.Three different cordis packages were returned with only two cordis catheters (cath tempo 4f c2 65cm 2sh).The customer reports only two catheter tips broke, one was intact and used afterwards.The device kinked in the area of separation.The device separated approximately 2.5cm and 2.3cm from the distal end.There were no anomalies noted when removing the devices from the packaging.There were no anomalies noted during prep.There was no resistance met while advancing the device.There was no excessive torquing required.There was no resistance met while advancing the device over the guidewire.There was no resistance met while withdrawing the device.

Manufacturer Narrative

This event is related to (b)(4).Complaint conclusion: as reported, two tempo catheters (cath tempo 4f c2 65cm 2sh) became separated while being used with a non-cordis liver and biopsy set.The separated segments migrated to the lung arteries and were snared/retrieved using two unknown devices.Three different cordis packages were returned with only two cordis catheters (cath tempo 4f c2 65cm 2sh).The customer reports only two catheter tips broke, one was intact and used afterwards.The device kinked in the area of separation.The device separated at approximately 2.5cm and 2.3cm from the distal end.There were no anomalies noted when removing the devices from the packaging.There were no anomalies noted during prep.There was no resistance met while advancing the device.There was no excessive torqueing required.There was no resistance met while advancing the device over the guidewire.There was no resistance met while withdrawing the device.Two non- sterile units of product ¿cath tempo 4f c2 65cm 2sh¿ were received coiled inside a plastic bag.The devices were identified with number one and two in order to perform a separate evaluation.Per visual analysis, a body separation condition was observed located at 62.5cm from the hub.The separated section was not returned for analysis.No other damages or anomalies on the unit were detected.Per microscopic analysis, the edges of the separated present evidence of elongations, a frayed condition, and twisted characteristics.These characteristics suggest that the device was induced to stretching/pulling or twisting events that exceeded the material yield strength prior to the separation.No other anomalies were observed during analysis.Dimensional analysis was performed to verify the correct catheter id and od.Measurements were taken close to the separation area at 60cm from the hub.Dimensional analysis results were found within specification.Additionally, as the sterile lot number was not available, device history record review could not be performed.The complaints reported by the customer as ¿catheter (body/shaft) - separated - in patient¿ were confirmed.A separated condition on the body of both catheters was observed on the retuned units.Exact cause of the damage could not be conclusively determined during the analysis.Dimensional analysis results were found within specification and do not suggest that this damage could be related to the manufacturing process.During microscopic analysis, the evidence identified suggests that the device was induced to an excessive application of tension and torsion force that induced the separation.Vessel characteristics, although not provided, and/or procedural/handling factors might have contributed to the reported events.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters; straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.¿ neither the phr reviews nor the product analyses suggest that the found conditions could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH TEMPO 4F C2 65CM 2SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8869664
• MDR Text Key: 153580459
• Report Number: 9616099-2019-03127
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032008072
• UDI-Public: 20705032008072
• 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: 10/14/2019

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
• Device Operator: Health Professional
• Device Model Number: 451443V2
• Device Catalogue Number: 451443V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 10/14/2019
• Patient Sequence Number: 1