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

Model Number 451504V5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  Injury  

Event Description

As reported, after using a 5f uf tempo cath for an angiogram/runoff of the lower extremities, the distal tip of the catheter broke off in the patient.The patient was transferred to the hospital for vascular surgery after the attempt to snare the tip was unsuccessful.There were no anomalies noted to the device when removed from the package and no anomalies noted during the prep of the catheter.The device was inserted into the hemostatic valve.There was no resistance while advancing the catheter through the vessel and excessive torquing was not required.There was resistance/friction noted as the catheter was advanced over the.035 non-cordis wire.Resistance was felt while attempting to withdrawal the catheter from the patient; however, excessive force was not needed during the removal.The lesion was in the external iliac artery (eia) and was noted to have severe calcification.The two pieces were removed by using a snare.The case was not completed due tot the distal tip of the uf catheter separating in the eia/cfa.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18033665 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, after using a 5f uf tempo cath for an angiogram/runoff of the lower extremities, the distal tip of the catheter broke off in the patient.The patient was transferred to the hospital for vascular surgery after an attempt to snare the tip was unsuccessful.There were no anomalies noted to the device when removed from the package and no anomalies noted during the prep of the catheter.The device was inserted into the hemostatic valve.There was no resistance while advancing the catheter through the vessel and excessive torquing was not required.There was resistance/friction noted as the catheter was advanced over the.035 non-cordis wire.Resistance was felt while attempting to withdrawal the catheter from the patient; however, excessive force was not needed during the removal.The lesion was in the external iliac artery (eia) and was noted to have severe calcification.The two pieces were removed by using a snare.The case was not completed due to the distal tip of the uf catheter separating in the eia/common femoral artery (cfa).One non-sterile cath tempo 5f uf 65cm 5sh unit was received for analysis inside a plastic bag.During visual inspection, a separated condition was noted at 61.5 cm from the hub.No other anomalies were observed.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Dimensional analysis results were found within specification.Functional analysis was performed.Insertion/withdrawal test was performed, a 0.035¿ lab sample wire was inserted via hub and no resistance nor difficulty was noted.Sem analysis was performed near the separation.Results presented evidence of twisted conditions as well as striation marks and material elongations.A product history record (phr) review of lot 18033665 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿catheter (body/shaft) ¿ resistance/friction - inner lumen¿ was not confirmed since during functional test with the lab sample wire no resistance nor difficulty was felt, additionally, dimensional analysis was found within specification.The event ¿brite tip/distal tip ¿ separated - in-patient¿ was confirmed since a separation was noted near the distal tip.Material elongation patterns are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the brite tip/distal tip material was induced to a tensile force that exceeded the brite tip/distal tip material yield strength prior to the separation.The exact cause of the condition found could not be determined during analysis.Procedural and/or handling factors may have contributed to the reported condition.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported, after using a 5f uf tempo cath for an angiogram/runoff of the lower extremities, the distal tip of the catheter broke off in the patient.The patient was transferred to the hospital for vascular surgery after the attempt to snare the tip was unsuccessful.There were no anomalies noted to the device when removed from the package and no anomalies noted during the prep of the catheter.The device was inserted into the hemostatic valve.There was no resistance while advancing the catheter through the vessel and excessive torqueing was not required.There was resistance/friction noted as the catheter was advanced over the.035 non-cordis wire.Resistance was felt while attempting to withdrawal the catheter from the patient; however, excessive force was not needed during the removal.The lesion was in the external iliac artery (eia) and was noted to have severe calcification.The two pieces were removed by using a snare.The case was not completed due tot the distal tip of the uf catheter separating in the eia/cfa.The device will be returned for evaluation.

• Brand Name: CATH TEMPO 5F UF 65CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12965763
• MDR Text Key: 282323363
• Report Number: 9616099-2021-05153
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008327
• UDI-Public: (01)10705032008327(17)240531(10)18033665
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 451504V5
• Device Catalogue Number: 451504V5
• Device Lot Number: 18033665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2021
• 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
• Treatment: 035 NON-CORDIS WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female