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
(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 the pigtail end of the tempo 5f uf 65cm 5sh catheter as the end started to break off.There was no patient injury.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
During use there was a defect noted near the pigtail ends of two tempo 5f uf 65cm 5sh catheters.Additional information was received stating the tips were kinked/bent and one of the catheter tips was hanging by a tiny piece.There was no patient injury.The reported event happened in the aorta while directing the catheters.The devices were prepped according to the instruction for use (ifu) and there was no difficulty removing the products from the packaging.There were no damages to the device packaging.There was no excessive force used during the procedure.The devices were removed from the patient in one piece.A non cordis catheter was used to complete the procedure.Six other devices were also returned that were reported as kinked/bent.The reported ¿brite tip/distal tip-catheters cracked in patient¿ could not be confirmed as the device was not returned for analysis.A product history record (phr) review of lot 17650755 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip-catheters cracked in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristic and procedural and handling factors, while unknown, may have contributed to the reported event as these characteristics are known to cause damage to catheters.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.According to the instructions for use, which is not intended as a mitigation ¿torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer.¿ neither the phr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.The reported ¿brite tip/distal tip ¿ catheters kinked/bent¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural and handling factors, while unknown, may have contributed to the reported event as these characteristics are known to cause damage to catheters.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.According to the instructions for use, which is not intended as a mitigation ¿torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer.¿ neither the phr review nor the event description suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.
Additional Manufacturer Narrative
During use in an unknown procedure, there was a defect noted near the distal end of two tempo 5f uf 65cm 5sh catheters.One of the tips was noted to be kinked/bent, the other was hanging on by a small piece.The event has happened in the aorta while directing the catheter.The devices were removed from the patient intact.There was no patient injury reported.A non cordis catheter was used to complete the procedure.The devices were prepped according to the instruction for use (ifu), there was no difficulty removing the devices from the packaging.There were no damages to the device packaging.There was no excessive force used during the procedure.Nine other devices were also returned that reported to be were kinked/bent.Per visual analysis, no anomalies were noted on the devices.Dimensional analysis was not performed due to no anomalies being noted in the evaluated devices.Microscopic analysis was not performed due to no anomalies being noted in the evaluated devices.The reported ¿brite tip/distal tip ¿ catheters-cracked - in-patient¿ and ¿brite tip/distal tip ¿ catheters-kinked/bent¿ was not confirmed.Per visual analysis, no anomalies were observed on the received devices.The exact cause of the events could not be determined; however procedural factors may have contributed to the perception of a kink/bent and cracked catheter.As per 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.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.¿ neither the phr review nor the product analyses suggest that the reported events are related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
Additional Manufacturer Narrative
This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• 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: 7230532
• Report Number: 9616099-2018-01818
• Device Sequence Number: 19203774
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/03/2019

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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Distributor Facility Aware Date: 01/02/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 02/05/2018; 04/17/2018; 11/21/2018; 12/13/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/05/2018; 04/18/2018; 12/06/2018; 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1