MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  Injury  

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.

Event Description

As reported, there was relocation of the marker bands and tear off of the 110 cm.5 fr.Mb pigtail 6sh catheter in the patient.There was no reported patient injury.The product will be returned for inspection.Additional information received indicated that the device did separate in the patient.There was no withdrawal difficulty reported.The marker bands shifted and stayed on the catheter but did not dislodge.A snare was used to successfully remove the separated product from the patient.No target lesion/target lesion characteristic information was available.There was no reported difficulty advancing the catheter into the patient to the intended target lesion.It was not known if the device was inserted through a stopcock instead of a hemostatic valve.There was no reported excessive force used during the procedure or any reported excessive manipulation.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.It was unknown what was done to complete the procedure after the reported product issue or if the procedure completed successfully.No additional information is available.

Manufacturer Narrative

Complaint conclusion: as reported, the marker bands shifted on the catheter but did not dislodge and there was a separation of the pigtail catheter in the patient.There was no reported patient injury.A snare was used to successfully remove the separated product from the patient.No target lesion/target lesion characteristic information was available.There was no reported difficulty advancing the catheter into the patient to the intended target lesion.Nor was any withdrawal difficulty reported.It was not known if the device was inserted through a stopcock or a hemostatic valve.There was no reported excessive force used during the procedure or any reported excessive manipulation.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.No additional information is available.  the product was returned for inspection.A non-sterile diagnostic cath mb 5f pig 110cm 6sh was received for analysis coiled inside a plastic bag.Per visual analysis the catheter was received separated in two parts at 23 cm from distal section.Also, during the visual analysis was observed that 15 out of 20 marker bands were found moved/ out of position at distal section of unit.The distal section of unit was observed under vision system and the marker band marks on unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).  however, the unit presented elongation on catheter body from 11 cm to 22 cm from distal near to the seventh marker band.The catheter showed 15 marker bands (from mb 6 to mb 20) moved from their original place and pile up together.Only marker bands 1 to 5 remained in their original positions.(the position of the marker bands is numerated from the distal end to the hub).No other anomalies were found.Dimensional analysis.The catheter od/id was measured near of separated area and results were found within specification.Also, the catheter id and od of body shaft was measured between marker bands and were found within specification.Except from od dimension # 7 to dimension # 10; where elongation that corresponds to the elongated area.Functional analysis could not be performed due to the condition as was received the product for the analysis (catheter body separated).Sem analysis was required to determine the cause of the separation and results showed that the distal and proximal sections of the rupture presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.No other issues were noted during sem analysis.  the complaint reported by the customer as ¿marker band- offset/out of position-in patient and catheter (body/shaft) - separated - in-patient¿¿ was confirmed due to received product condition.However the exact cause of these conditions found could not be conclusively determined during the analysis since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.Sem results showed that the distal and proximal sections of the rupture presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.And the analysis results showed that the sections with evidence of marker band displacement presented no anomalies or evidence as to determine what caused the displacement; however, it can be assured that the marker bands were placed on the correct position at a certain time owing to the outer diameter reduction of the body.Additionally, diagnostic catheters manufacturing process flow for marker band catalog 532598b was reviewed as well as controls in place to verify the catheters for marker bands defects and no anomalies found.No actions will be taken at this time since measurements and marker band marks show that all marker bands were placed on the correct position at a certain time due to the outer diameter reduction of the body present on catheter tip.Based on the information available, it appears that the difficulty experienced may have been caused by the operational context of the device and is not related to a product quality issue.As noted in the sem analysis the distal and proximal sections of the separated catheter presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.This stretching may also been responsible for the marker bands to dislocate from their set locations.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 110CM 6SH
• 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: 6118281
• MDR Text Key: 60567118
• Report Number: 9616099-2016-00744
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915836
• 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
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17557829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2016
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention