MAUDE Adverse Event Report: CORDIS DE MEXICO 5F TEMPO AQUA 0.038 100CM JR4; DIAGNOSTIC CARDIOLOGY CATHETER (DQO)

Catalog Number SRD7085

Device Problems Crack (1135); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2014

Event Type  malfunction  

Event Description

The report received from the affiliate indicated that prior to use in the patient, when the physician opened the packaging of the 100 cm.5 fr.Tempo aqua jr4 diagnostic catheter, he saw that some material of the catheter was protruding from the catheter.He then decided it was too dangerous to use that catheter for the patient, in case that material was swept into the vessel.There was no reported patient injury.The product was not clinically used in a patient.Another catheter was used to complete the procedure successfully.A picture is attached.Additional information received indicated: the luer hub appeared to be cracked/split and the protruding material was catheter material.There was no damage noted to the product packaging upon inspection prior to opening.There was no reported difficulty removing the product from the packaging.There was no other product issue noted with the catheter.The product was prepped properly according to the instructions for use (ifu).

Manufacturer Narrative

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

The report received from the affiliate indicated that prior to use in the patient, when the physician opened the packaging of the 100 cm.5 fr.Tempo aqua jr4 diagnostic catheter, he saw that some material of the catheter was protruding from the catheter.The device was not used in the patient and no patient injury was reported.Another catheter was used to complete the procedure successfully.The luer hub appeared to be cracked/split and the protruding material was catheter material.There was no damage noted to the product packaging upon inspection prior to opening.There was no reported difficulty removing the product from the packaging.There was no other product issue noted with the catheter.The product was prepped properly according to the instructions for use (ifu).A non sterile 5f tempo aqua.038 100cm jr4 catheter was received for analysis coiled inside a plastic bag.Per visual analysis, a flash was found hanging from the hub thread of catheter.The flash was observed to be located in the line of partition, at the point where the two mold cavities meet to form the hub thread.No more anomalies were found.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.The complaint reported by the customer as ¿diagnostic cardiology catheter- luer hub- cracked-prior to use¿ was not confirmed during the analysis since no indications of hub cracked observed.However, a flash was found hanging from the hub thread of catheter.Escalation notification took place, given that the reported failure appears to be related to the manufacturing process.The reported ¿luer hub ¿ cracked prior to use¿ was not confirmed; however, analysis confirmed a flash hanging from the hub of the catheter.A risk analysis has been initiated to further investigate this issue.

• Brand Name: 5F TEMPO AQUA 0.038 100CM JR4
• Type of Device: DIAGNOSTIC CARDIOLOGY CATHETER (DQO)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 32580 ; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3628464
• MDR Text Key: 18855729
• Report Number: 9616099-2014-00103
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2014

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: 08/31/2016
• Device Catalogue Number: SRD7085
• Device Lot Number: 15981558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 02/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1