MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

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 was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the 65 cm.Pigtail 8sh mb diagnostic catheter broke suddenly during removal from the patient.There was no reported patient injury.The product will not be returned for inspection.Addendum: the product was returned for inspection.The preliminary report indicated that the product was received in pieces.Multiple attempts to obtain additional information have been unsuccessful.

Manufacturer Narrative

While withdrawing the diagnostic catheter from the patient it reportedly separated in two pieces during removal.There was no reported patient injury.Multiple attempts to obtain additional information have been unsuccessful.  the product was returned for inspection.A review of the manufacturing documentation associated lot 17517063 revealed no anomalies during the manufacturing and inspection processes.No nonconformance records were issued for this lot.No excursions were found for lot 17517063.A non-sterile cath mb 5f pig 65cm 8sh was received inside of a plastic bag.Per visual analysis the catheter was received separated in two parts at 23 cm from distal section.Also, stiff condition was observed on the catheter from distal section.Blood residues were observed on the unit.No other damages/anomalies were observed.Dimensional analysis.The catheter od/id was measured near of separated areas and results were found within specification.The catheter was inspected under vision system and elongations were observed on the separation areas.The unit was sent to ftir and tga analysis in order to analyze the conditions found in the device during visual analysis; several analytical techniques were carried out over a complaint unit and results were compared against control sample to elucidate differences to aid in determining the cause of brittle and stiff conditions found in the complaint unit.Ftir analysis ruled out change in the chemical formulation used on body shaft of complaint unit since characteristic ir absorption bands of polyurethane material.The degradation of the material should be considered as the increase on intensity of absorption peaks and additional peaks these indicates the change in molecular structure caused by oxidation process that induce chain scissions, however this conclusion is based on the patterns observed in the resultant ir spectrum.For complaint body shaft tga test reveals an advanced degradation condition caused by an external source such as light, humidity, temperature and others, these results concords with ft-ir analysis.Body shaft have an advanced state of degradation directly affecting their thermal performance.  the failure reported by the customer as ¿catheter (body/shaft) - separated - in-patient¿ was confirmed due to condition of the received product.The cause of the event experienced by the customer could not be conclusively determined.However, per event description and product analysis, procedural/handling factors could be contributed on this issue.Controls are in placed at the final assembly and packaging processes to detect this kind of issue.Product analysis, dhr review and ftir/tga analysis results do not suggest that these conditions are related to the manufacturing process.Based on the information available, it appears that the difficulty experienced may have been caused during shipping or storage of the device and is not related to a product quality issue.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.No corrective or preventive action will be taken, given that; with the information provided the reported failure/event does not appear to be related to the manufacturing process.

• Brand Name: CATH MB 5F PIG 65CM 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: 6122528
• MDR Text Key: 60751305
• Report Number: 9616099-2016-00751
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 17517063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/09/2016
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1