MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48005015X

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Event Description

As reported, the scrub nurse tried to flush a saber 5mm15cm 150 but it would not flush.The device was replaced with another saber balloon catheter and it was flushed successfully.There was no reported patient injury.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The device was not used in the patient.The device was opened in the sterile field.The issue occurred during prep for a pta procedure.The device was inspected for damages prior to use and there were no visible damages; only the reported issue.There was no difficulty removing the product from the hoop.The physician also attempted to flush the device but was unable to.It seemed "as if the tip was closed".No solution would the catheter when attempting to flush.The device was later returned for analysis.Addendum: product analysis revealed a piece of an unknown material tucked inside the guide wire lumen could be observed.

Manufacturer Narrative

The product history review was completed but has been re evaluated due to need for additional testing.Final updated phr is in process.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the scrub nurse tried to flush a saber 5mm x 15cm 150, but it would not flush.The device was replaced with another saber balloon catheter, and it was flushed successfully.There was no reported patient injury.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The device was not used in the patient.The device was opened in the sterile field.The issue occurred during prep for a pta procedure.The device was inspected for damages prior to use and there were no visible damages; only the reported issue.There was no difficulty removing the product from the hoop.The physician also attempted to flush the device but was unable to.It seemed "as if the tip was closed".No solution would the catheter when attempting to flush.The device was returned for analysis.A non-sterile saber 5mm x 15cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, neither anomalies nor damages could be observed by the naked eye.Flushing, insertion, and withdrawal testing was intended to be performed on the device.The guidewire lumen was unable to flushed.Then, a guidewire was attempted to be inserted; an appropriate.018¿ lab sample guide wire was inserted via tip and vice versa, via hub with unsuccessful results.The guidewire could not be passed entirely through the guidewire lumen of the unit.The guidewire was advanced via tip and vice versa, via hub and stopped at approximately 102cm from the hub and no longer advanced, an obstruction was felt at this point.Per microscopic analysis, the gw was cut/dissected at the obstructed area and inspected under the vision system.A piece of unknown material was noted to be tucked inside the guidewire lumen.The unknown material was observed accordioned (zigzag) inside the guidewire lumen.The material was intended to be removed from the guidewire lumen; however, the unknown material unraveled.The dissected section of the saber inner body with the unknown material was sent to the analytical lab to perform a ft-ir analysis to confirm or discard if the unknown material matches the inner body composition.Per analytical ft-ir test results, the composition obtained from the infrared spectra of the unknown material is found to be that of a high-density polyethylene.Based on ir results, it can be concluded that the described unknown material matches the normal composition of the inner body component.Per analytical analysis results, the material found inside the complaint unit was positively identified as high-density polyethylene through ftir analysis and no foreign material was present in the unit.A possible scenario for this defect to occur is that the use of the mandrels in the downstream processes could have caused an excessive friction that resulted in the eventual delamination of the inner layer.Once detached from the outer layer, the delamination of the inner layer material continued as the mandrel was advanced further into the tubing, compressing the delaminated material in an accordioned fashion, as observed in the complaint investigation.It could not be concluded if the reported complaint was a problem caused during extrusion of the component materials or at the supplier downstream processes, or if it was a combination of both.Nonetheless, the escalation process was to be followed on this complaint unit to document the malfunction observed.A product history record (phr) review of lot 82160731 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system flushing difficulty - during prep¿ and subsequent findings of ¿guidewire lumen obstructed¿ was confirmed via device analysis.However, the exact cause cannot be determined.During analysis the material noted inside the guidewire lumen was high-density polyethylene, the same material that is comprised of the guidewire lumen inner body.It is likely the accordioned piece was sheared off at some point due to the interaction of the lining with a sharp object.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.¿ the product analysis suggests that the event experienced by the customer may be associated to the manufacturing process.Therefore, a risk assessment has been initiated for further investigation.

• Brand Name: SABER 5MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13074925
• MDR Text Key: 290462378
• Report Number: 9616099-2021-05224
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069189
• UDI-Public: 20705032069189
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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: 09/30/2021
• Device Model Number: 48005015X
• Device Catalogue Number: 48005015X
• Device Lot Number: 82160731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2018
• 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
• Treatment: SABER PTA BALLOON CATHETER (CATALOG #48005010X)
• Patient Sex: Male