MAUDE Adverse Event Report: CORDIS DE MEXICO CATH NYLEX 5F PIG 90CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 526511

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of two products involved with the reported event.(b)(4).  the device is expected to be returned for analysis; however, the device has not yet been received.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the non-cordis guidewire got stuck in the catheter upon completion of the case.Wire and catheter had to be withdrawn together out through the sheath.Upon inspection, they found fibrous material (described as looking like dental floss) within the lumen.They flushed and sampled another catheter from the same lot number with same result.Another product from another lot was used to complete the procedure with no further complications.There was no patient injury.The devices will be returned for analysis.The intended procedure was an inferior vena cava (ivc) gram.There were no damages or anomalies noted to the catheters or packaging prior to use.The devices were handled and prepped according to the instructions for use (ifu).There was no difficulty experienced as the catheters were initially advanced over the guidewire.There were no damages noted to the guidewire during use and it was not reshaped in any way.No unusual force was applied during the procedure and it was not torqued against resistance.The catheter and guidewire were easily removed from the patient when it was removed as a unit.A new wire, new catheter was used after the first occurrence of the fibrous material was noted.However, the same telfa pad used to wipe the wire prior to loading the catheter.The reported stated that perhaps the material was from the telfa pad.There was no suspicion that any of the fibrous material noted was separated into the patient.

Manufacturer Narrative

The device was received for analysis and was updated accordingly.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.This is one of two products involved with the reported event.The manufacturing reference number for this event is b)(4) (9616099-2016-00757).The manufacturing reference number for the other complaint is (b)(4) (9616099-2016-00756).

Manufacturer Narrative

This is one of two products involved with the reported event.The manufacturing reference number for this event is (b)(4) (9616099-2016-00757).The manufacturing reference number for the other complaint is (b)(4) (9616099-2016-00756).Complaint conclusion: as reported, the non-cordis guidewire got stuck in the catheter upon completion of the case.Wire and catheter had to be withdrawn together out through the sheath.Upon inspection they found fibrous material (described as looking like dental floss) within the lumen.They flushed and sampled another catheter from the same lot number with same result.Another product from another lot was used to complete the procedure with no further complications.There was no patient injury.The devices will be returned for analysis.The intended procedure was an inferior vena cava (ivc) gram.There were no damages or anomalies noted to the catheters or packaging prior to use.The devices were handled and prepped according to the instructions for use (ifu).There was no difficulty experienced as the catheters were initially advanced over the guidewire.There were no damages noted to the guidewire during use and it was not reshaped in any way.No unusual force was applied during the procedure and it was not torqued against resistance.The catheter and guidewire were easily removed from the patient when it was removed as a unit.A new wire, new catheter was used after the first occurrence of the fibrous material was noted.However, the same telfa pad used to wipe the wire prior to loading the catheter.The reported stated that perhaps the material was from the telfa pad.There was no suspicion that any of the fibrous material noted was separated into the patient.  one non-sterile unit from product cath nylex 5f pig 90cm 8sh and a 0.035¿ guide wire were received coiled inside of a plastic bag.Per visual analysis, the guide wire was received inserted into the catheter, and a foreign material was observed attached to guide wire.No other anomalies were observed on the received units.Per functional analysis, the guide wire was removed from the catheter and resistance was felt.When the guide wire was released, it was observed that the foreign material was causing the resistance.The guidewire with the foreign material was submitted to the qa analytical laboratory for ftir identification test.Per ftir (abstract), spectra from material showed characteristic ir bands, which are associated to a biological material.The composition of the tissue is mostly of lipids, proteins and nucleic acids.Ftir results concluded that the identification of the material was based on peak assignments and reference comparison.Based on this data, it is suggested that the material found attached to the guidewire has a biological composition similar to the one shown by human tissue. review of lot 17393609 revealed no anomalies during the manufacturing and inspection processes.The reported ¿coating ¿ delaminated - in-patient¿ was not confirmed for the product returned under (b)(4) since no foreign mater was observed on the received catheter during the visual and functional analysis.The cause of reported condition could not be conclusively determined during the analysis.However, the reported ¿coating ¿ delaminated - in-patient¿ for the product returned under (b)(4) was not confirmed since foreign material ftir analysis results indicated that the material was human tissue.The cause of reported condition could not be conclusively determined.According to the ifu, ¿exercise care when removing guidewires from multiple-curve catheters.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ the product analyses and dhr review results do not suggest that the reported condition could be related to the manufacturing process.In addition per ftir analysis results suggest procedural factors might have contributed to this issue.Therefore, no actions will be taken at this time.

• Brand Name: CATH NYLEX 5F PIG 90CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6126666
• MDR Text Key: 60878579
• Report Number: 9616099-2016-00757
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 526511
• Device Lot Number: 17393609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/04/2016
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/20/2016; 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK 0.035 145CM "J" GUIDEWIRE