MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JL3.5 100CM; CATHETER, PERCUTANEOUS

Model Number 67000200

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18020856 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the middle part of a 6f.070 jl3.5 100cm vista brite tip guiding catheter was found broken as the catheter was being pulled during the procedure; it had a puncture/cut.Therefore, the product was not available.¿broken¿ is meant as the device was puncture/cut.The catheter was removed intact from the patient.There was withdrawal difficulty of the device that led to the device being pulled.There was no reported patient injury.The device was used in a percutaneous coronary intervention (pci) procedure.The access site was the femoral artery.There was no difficulty experienced when prepping the device.There was no contralateral approach used.The vessel at the target site was mildly calcified, and mildly tortuous.The vessels accessing the target site were mildly calcified, and mildly tortuous with an acute angle of 30-40 degrees.The device was not used for a chronic total occlusion (cto).There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of the vista brite tip catheter and has used the device several times prior to this procedure.The device was prepared and used in accordance with ifu instructions.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h10.As reported, the middle part of a 6f.070 jl3.5 100cm vista brite tip guiding catheter was found broken as the catheter was being pulled during the procedure; it had a puncture/cut.Therefore, the product was not available.¿broken¿ means the device was puncture/cut.The catheter was removed intact from the patient.There was withdrawal difficulty of the device that led to the device being pulled.There was no reported patient injury.The device was used in a percutaneous coronary intervention (pci) procedure.The access site was the femoral artery.There was no difficulty experienced when prepping the device.There was no contralateral approach used.The vessel at the target site was mildly calcified, and mildly tortuous.The vessels accessing the target site were mildly calcified, and mildly tortuous with an acute angle of 30-40 degrees.The device was not used for a chronic total occlusion (cto).There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of the vista brite tip catheter and has used the device several times prior to this procedure.The device was prepared and used in accordance with ifu instructions.One non-sterile unit of catheter 6f.070 jl3.5 100cm was received for analysis.During visual inspection, the body/shaft was found separated at 36 cm from the hub.Additionally, the unit was found twisted on the end of the separation and kinked/bent on the body/shaft.The kinks were located approximately 25, 26.7 and 14 cm from the hub.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis of the separated area presented evidence of elongations and a twisted condition on the material.A product history record (phr) review of lot 18020856 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft) ¿ withdrawal difficulty¿ was not confirmed.Due the nature of the complaint, the event cannot be properly evaluated.The event reported by the customer ¿catheter (body/shaft) ¿ puncture/cut - in-patient¿ was not confirmed.These damages were not observed on the unit.The event ¿catheter (body/shaft) ¿ separated¿ was confirmed.A separated condition was found on the body shaft.The elongations found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft was induced to a tensile force that exceeded the material yield strength prior to the separation.Additionally, the twisted condition noted on the end of the separation suggests the separation occurred while manipulating the device.The exact cause of these conditions could not be conclusively determined during analysis.However, excessive manipulation of the catheter to overcome withdrawal difficulty 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, ¿ 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).¿ 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 middle part of a 6f.070 jl3.5 100cm vista brite tip guiding catheter was found broken as the catheter was being pulled during the procedure; it had a puncture/cut.Therefore, the product was not available.¿broken¿ is meant as the device was puncture/cut.The catheter was removed intact from the patient.There was withdrawal difficulty of the device that led to the device being pulled.There was no reported patient injury.The device was used in a percutaneous coronary intervention (pci) procedure.The access site was the femoral artery.There was no difficulty experienced when prepping the device.There was no contralateral approach used.The vessel at the target site was mildly calcified, and mildly tortuous.The vessels accessing the target site were mildly calcified, and mildly tortuous with an acute angle of 30-40 degrees.The device was not used for a chronic total occlusion (cto).There were no visible signs of device/package damage prior to use.The physician achieved certification on the use of the vista brite tip catheter and has used the device several times prior to this procedure.The device was prepared and used in accordance with ifu instructions.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: visual inspection of device received shows it was broken in two.Product evaluation found separated at 36 cm from the hub.Additionally, the unit was found twisted on the end of the separation and kinked/bent on the body/shaft, those kinks were located approximately at 25, 26.7 and 14 cm from the hub.

• Brand Name: 6F .070 JL3.5 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 14957140
• MDR Text Key: 298124701
• Report Number: 9616099-2022-05788
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032019863
• UDI-Public: 20705032019863
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 67000200
• Device Catalogue Number: 67000200
• Device Lot Number: 18020856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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