MAUDE Adverse Event Report: CORDIS DE MEXICO CATH TEMPO 4F JB 1 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451423H0

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during the intra-arterial chemotherapy procedure the radiopaque tip of the 100 cm.The 4 fr.Tempo jb 1 diagnostic catheter detached from the catheter.It is not known if the product will be returned for inspection.There was no reported patient injury.

Manufacturer Narrative

Additional information received indicated that the reported product issue was that during manipulation of the catheter internally to the patient the guidewire pierced a catheter structure and exited sideways.There was no reported patient injury.The patient¿s hospitalization was not prolonged.No piece of the product fell into the patient.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Based on the finding of the product analysis, the product malfunction code of catheter/body/shaft-burst in patient is being added.As reported, during the intra-arterial chemotherapy procedure the radiopaque tip of the 100 cm.4 fr.Tempo jb 1 diagnostic catheter detached from the catheter.There was no reported patient injury. additional information received indicated that the reported product issue was that during manipulation of the catheter internally to the patient the guidewire pierced a catheter structure and exited sideways.There was no reported patient injury.The patient¿s hospitalization was not prolonged.No piece of the product fell into the patient.One non-sterile unit of cath tempo 4f jb 1 100cm was received coiled inside a plastic bag.Per visual analysis a rupture was found on the catheter tip at 2.3cm from catheter distal end.The ruptured catheter body was sent to sem analysis.Results showed that the analyzed material presents evidence of material deformation and elongations that suggest the application of a force by an unknown object from the inside to the outside of the catheter body that induced the material deformations and the rupture observed.No other anomalies were found during sem analysis.The inner diameter/outer diameter were measured near to tip rupture condition and results were found within specification.A device history record (dhr) review of the manufacturing documentation associated with lot 17445517 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The complaint reported by the customer as ¿brite tip/distal tip - separated-in patient¿ was not confirmed since the catheter tip was not received separated.Instead of distal tip separation, a ¿catheter (body/shaft) ¿ burst¿ was found on the catheter tip area.The cause of the catheter tip damaged/ruptured condition found could not be conclusively determined during the analysis.Based on the limited information available for review, procedural/handling factors may have contributed to this issue reported as evidenced by the material deformation and elongations.As stated in the instructions for use (ifu), ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the dhr review nor the product analysis suggest that the conditions reported are related to the manufacturing process of the unit.Therefore, no corrective and preventive actions will be taken at this time.

• Brand Name: CATH TEMPO 4F JB 1 100CM
• 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: 6396211
• MDR Text Key: 69815712
• Report Number: 9616099-2017-00959
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2017

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: 02/28/2019
• Device Model Number: 451423H0
• Device Catalogue Number: 451423H0
• Device Lot Number: 17445517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2017
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/29/2017; 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• 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