MAUDE Adverse Event Report: CATH TEMPO 5F C2 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451543V0

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr complaint number#: case-(b)(4).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.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, two (2) 5f 65cm cobra (c2) tempo diagnostic catheters were kinked/cracked (snapped) when removed from the patient.Both catheters were intact when removed from the packaging and handed to the doctor but when removed from the patient they came out snapped.There was no reported patient injury.The devices were stored per labelling and opened in sterile field.The product was stored and handled according to the instructions for use (ifu).There was no difficulty removing the device from the sterile packaging.The device was prepped per the ifu.There was no difficulty experienced in prepping the device.The product, or any of the other devices used with it, had not been resterilized.A contralateral approach was not used.The target site was the common iliac.The access site was femoral.The lesion was not calcified.There was no vessel tortuosity.The was no stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the device through the introducer, over the guidewire, or to the target lesion.The other devices used with the product did not kink nor bend at any time.There was no unusual force used at any time during the procedure.The procedure was completed with other products.The 2 devices are expected to be returned for analysis with 3 unused devices.

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04735 two non-sterile cath tempo 5f c2 65cm units were received for analysis inside a plastic bag.The devices were unpacked to proceed with the product evaluation.The other unit was evaluated under case-(b)(4).During visual inspection, a separated condition was noted approximately at 6.4 cm from distal tip.Additionally, a cracked portion was noted approximately at 14.7 cm from distal tip.Also, a yellowish hub was noted, on the image below can be observed the difference on the color of the hub returned and a lab sample.No other anomalies were observed during the analysis.Due the separated and cracked conditions found on the body, a sem analysis was performed, and results showed that the separated area of the body/shaft from the cath tempo 5f c2 65 cm unit presented evidence of elongations.Plastic deformation resulting in diameter reduction was observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the body/shaft material, the ductile dimples, plastic deformation and the diameter reduction observed on the braid wires, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the braidwire separation.No other anomalies were observed during sem analysis.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, two 5f 65cm cobra (c2) tempo diagnostic catheters were kinked/cracked (snapped) when removed from the patient.The target site was the common iliac.The procedure was performed via femoral access.A contralateral approach was not used.There was no vessel tortuosity or stenosis, and the lesion was not calcified.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the device over the guidewire, through the introducer, or to the target lesion.No unusual force was used at any time during the procedure.The other devices used with the product did not kink or bend at any time.The product was stored, prepped, and handled according to the instructions for use (ifu).There was no difficulty experienced while removing the device from the sterile packaging or while prepping it.Both catheters were opened in the sterile field and intact when removed from the packaging and handed to the doctor.Neither the affected product nor any of the devices used with it, had not been resterilized.The procedure was completed with other unknown products.There was no reported patient injury.Two non-sterile cath tempo 5f c2 65cm units were received for analysis.The first unit was analyzed under 00158612-1 and the second unit was analyzed under 00158612-2.00158612-1: during visual inspection, a separated condition was noted approximately 6.4 cm from distal tip.Additionally, a crack was noted approximately 14.7 cm from the distal tip.A yellowish discoloration was noted to the hub.No other anomalies were observed during the visual analysis.Sem analysis was performed.Results of the separated area of the body/shaft showed evidence of elongations.Plastic deformation resulting in diameter reduction was observed on braid wires.Ductile dimples were found on the separated braid wire surfaces.Sem analysis of the cracked area provided no evidence as to what could have caused the body/shaft to crack.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17837647 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) ¿ kinked/bent - in-patient¿ was not confirmed since no kinks were found.The reported events ¿catheter (body/shaft) ¿ cracked - in-patient¿ and "catheter (body/shaft) - separated" were confirmed since cracks and a separation were present on both returned devices.Exposure to heat, moisture, or ultraviolet light can accelerate degradation of the catheter¿s integrity.The yellowish condition noted to the catheter¿s hub could be from exposure to improper environmental conditions that may have led to the cracked plastic and discolorations.The elongations found on the body/shaft material, ductile dimples, plastic deformation, and the diameter reduction observed on the braid wires, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the braid wire separation.Shipping/handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use (yellowish discoloration).Any product with damage is not to be used.Although not intended as a mitigation of risk, 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), store in a cool, dark, dry place.Do not use open or damaged packages.Exposure to temperatures above 54°c (130°f) may damage the catheter.Based on the information available, product analysis, 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.This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04735.

• Brand Name: CATH TEMPO 5F C2 65CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12230794
• MDR Text Key: 266055372
• Report Number: 9616099-2021-04734
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008679
• UDI-Public: 10705032008679
• 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,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 451543V0
• Device Catalogue Number: 451543V0
• Device Lot Number: 17837647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2019
• 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