MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451404V5

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the shaft of the 4f uf cath tempo 65cm broke into two separate pieces while inside the patient¿s vessel while still on the.035x260cm cordis amplatz super stiff wire.This happened while removing/withdrawing from the patient.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).The was no apparent damage noted on the device prior to use.The intended lesion was in the left superficial femoral artery (sfa).The vessel was noted to have no tortuosity; however, the lesion was noted to have moderate calcification.There was no resistance/friction noted while advancing the catheter though the vessel and/or while the catheter was advanced over the.035 wire.Unusual force was not used during withdrawal of the catheter.The case was completed with the use of an unknown device (not a catheter).The device will be returned for evaluation.

Manufacturer Narrative

As reported, the shaft of a 4f universal flush cath tempo 65cm broke into two separate pieces while inside the patient¿s vessel.The catheter was inserted over an.035¿ x260cm cordis amplatz super stiff wire.The separation occurred while removing/withdrawing it from the patient.There was no reported patient injury.The device was prepped per the instructions for use (ifu).There was no apparent damage noted to the device prior to use.The intended lesion was in the left superficial femoral artery (sfa).The vessel was noted to have no tortuosity however, the lesion was noted to have moderate calcification.There was no resistance/friction noted while advancing the catheter though the vessel and/or while the catheter was advanced over the.035¿ wire.Unusual force was not used during withdrawal of the catheter.The case was completed with the use of an unknown device (not a catheter).The product was not returned for analysis.A product history record (phr) review of lot 18031759 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- separated - in-patient¿ could not be confirmed.Storage, handling and/or procedural factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.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.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.¿ 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, the shaft of the 4f uf cath tempo 65cm broke into two separate pieces while inside the patient¿s vessel while still on the.035x260cm cordis amplatz super stiff wire.This happened while removing/withdrawing from the patient.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).The was no apparent damage noted on the device prior to use.The intended lesion was in the left superficial femoral artery (sfa).The vessel was noted to have no tortuosity; however, the lesion was noted to have moderate calcification.There was no resistance/friction noted while advancing the catheter though the vessel and/or while the catheter was advanced over the.035 wire.Unusual force was not used during withdrawal of the catheter.The case was completed with the use of an unknown device (not a catheter).The device will not be returned for evaluation.Additional information was requested; however, the information was not obtained.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d9, additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the shaft of the 4f uf cath tempo 65cm broke into two separate pieces while inside the patient¿s vessel while still on the.035x260cm cordis amplatz super stiff wire.This happened while removing/withdrawing from the patient.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).The was no apparent damage noted on the device prior to use.The intended lesion was in the left superficial femoral artery (sfa).The vessel was noted to have no tortuosity; however, the lesion was noted to have moderate calcification.There was no resistance/friction noted while advancing the catheter though the vessel and/or while the catheter was advanced over the.035 wire.Unusual force was not used during withdrawal of the catheter.The case was completed with the use of an unknown device (not a catheter).The device will be returned for evaluation.Additional information was requested; however, the information was not obtained.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, h1, h2, h3 and h6.As reported, the shaft of the 4f uf cath tempo 65cm broke into two pieces inside the patient¿s vessel while on an.035x260cm cordis amplatz super stiff wire.This happened while removing/withdrawing from the patient.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).The was no apparent damage noted on the device prior to use.The intended lesion was in the left superficial femoral artery (sfa).The vessel was noted to have no tortuosity; however, the lesion was noted to have moderate calcification.There was no resistance/friction noted while advancing the catheter though the vessel and/or while the catheter was advanced over the.035 wire.Unusual force was not used during withdrawal of the catheter.The case was completed with the use of an unknown device (not a catheter).One non-sterile cath tempo 4f uf 65cm 5sh unit was received for analysis.Per visual analysis, the body/shaft was observed separated at the distal end of the unit.The separated distal end of the unit was not returned for analysis.Sem analysis results on the separated body/shaft presented evidence of elongations and scratch marks.Evidence of sheared off braid wires were found on the separated braid wire surfaces.A product history record (phr) review of lot 18031759 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event ¿catheter (body/shaft) - separated - in-patient¿ was confirmed since the body/shaft of the unit was observed separated.The elongations and scratch marks found on the body/shaft material and the sheared off braid wires, are commonly caused during the interaction of the device with a sharp object.Therefore, it is assumed the separation was due to the interaction of the unit with a sharp.Procedural factors such as vessel calcification or an interaction between the catheter and a sharp medical device may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿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.¿ 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, the shaft of the 4f uf cath tempo 65cm broke into two separate pieces while inside the patient¿s vessel while still on the.035x260cm cordis amplatz super stiff wire.This happened while removing/withdrawing from the patient.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).The was no apparent damage noted on the device prior to use.The intended lesion was in the left superficial femoral artery (sfa).The vessel was noted to have no tortuosity; however, the lesion was noted to have moderate calcification.There was no resistance/friction noted while advancing the catheter though the vessel and/or while the catheter was advanced over the.035 wire.Unusual force was not used during withdrawal of the catheter.The case was completed with the use of an unknown device (not a catheter).The device will be returned for evaluation.Additional information was requested; however, the information was not obtained.

• Brand Name: CATH TEMPO 4F 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: 12931720
• MDR Text Key: 285225868
• Report Number: 9616099-2021-05098
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 18031759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 64 KG