MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JR 4 100CM; CATHETER, PERCUTANEOUS

Catalog Number 67008200

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17784705) 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.

Event Description

As reported, at the prep step of the jr4 guide catheter (6f.070 jr 4 100cm), the physician didn't flushed the jr4 guide catheter.He wiped only the outside of the jr4.The physician tried to measure the pressure after inserting the jr4 into the coronary artery.However, the pressure was no measured.So, he removed the jr4 from the coronary artery.Then, he flushed the jr4 and foreign substance came out of it.There was no reported patient injury.

Manufacturer Narrative

After further review of additional information received the following: event, concomitant medical products, date rec¿d by mfr, if follow-up, what type and device evaluated by mfr have been updated accordingly.Event: additional information received indicates that the product was stored and handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use and there were no anomalies noted when the device was taken out of the package.The seal of the package had not been opened and the device had not been previously re-shelved.There was no excessive force applied to the device during withdrawal from package.None of the devices used had been re-sterilized.The integrity of the sterile pouch had not been compromised.The actual product was not damaged and was prepped according to the ifu.The device prepped normally and flushing was completed during prep.There were no anomalies noted during or after the device was prepped.The device was removed easily and in one piece from the patient.The patient did not experience any complications as a result of the failure with the device.The procedure was completed successfully with another cordis catheter.During an unknown procedure, the physician removed the jr4 guide catheter (6f.070 jr 4 100cm) from the patient after the pressure of the coronary artery was unable to be measured.The physician flushed the jr4 and foreign substance came out of it.The procedure was completed successfully with another cordis catheter.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use and there were no anomalies noted when the device was taken out of the package.The seal of the package had not been opened and the device had not been previously re-shelved.There was no excessive force applied to the device during withdrawal from package.None of the devices used had been re-sterilized.The integrity of the sterile pouch had not been compromised.The actual product was not damaged and was prepped according to the ifu.The device prepped normally, and flushing was completed during prep.There were no anomalies noted during or after the device was prepped.The device was removed easily and in one piece from the patient.No other information was reported.The device was not returned for analysis.However, a foreign substance inside a glass container was received.Per visual analysis, the foreign substance appeared to be light brown, with a jelly-like consistency approximately a couple centimeters long.Per analytical test results, infrared spectroscopy was applied to determine the composition of the foreign substance.Results showed that based on the absorption bands observed in the ir spectrum obtained from the foreign material, it is suggested that this material has a biological composition like that shown by human tissue.A product history record (phr) review of lot: 17784705 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported, ¿catheter (body/shaft)- foreign material - in-patient¿ was confirmed due to the substance received even though the actual involved device was not returned for analysis.However, the analytical test results showed that it is suggested that this material has a biological composition like that shown by human tissue.Nonetheless, the exact cause of the mentioned human tissue found inside of the device could not be conclusively determined during the analysis.Procedural factors may have contributed to the event.Per the instructions for use (ifu), which is not intended as a mitigation, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.Prior to use, flush the guiding catheter lumen with a heparinized saline solution.Introduce the guiding catheter into the vasculature through the catheter sheath introducer, and/or over an indwelling guidewire using a percutaneous entry technique of choice.Set up a continuous heparinized saline flush through the sidearm of a hemostatic valve attached to the guiding catheter hub.Note: it is recommended that a continuous heparinized saline flush be maintained between the guiding catheter and any intraluminal device passed through it.Under fluoroscopic guidance, advance the guiding catheter over the guidewire or introducer until desired position is attained.Remove the guidewire or introducer prior to the introduction of other intravascular devices or infusion of contrast agents.The phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 6F .070 JR 4 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7806393
• MDR Text Key: 118111975
• Report Number: 9616099-2018-02338
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 67008200
• Device Lot Number: 17784705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1