MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002030X

Device Problem Partial Blockage (1065)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, a 2mm30cm 150 saber percutaneous transluminal angioplasty (pta) dilation catheter would not insert over a wire. Another saber pta catheter was used to complete the procedure. There was no injury to the patient. Resistance was felt and the balloon was not able to be placed over the wire and was never used in the patient. The device was stored and prepped according to the instructions for use. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components. No kinks or other damages were noted prior to use. The insertion difficulty was not caused by a blockage of possibly injectable material. The device was returned for analysis. A non-sterile saber 2mm x 30cm 150 was received coiled inside of a clear plastic bag. The device was unpacked to perform the product evaluation. The unit was inspected observing that the balloon is not inflated. No damages or anomalies were observed on the returned product. Functional analysis was performed, the guide wire lumen of the balloon catheter was attempted to be flushed. However, due to an obstruction, the water did not flow through the device. A lab sample guidewire of the appropriate size was inserted into the guidewire lumen of the balloon catheter through the distal tip. An obstruction was noticed approximately at 4cm from the proximal end. The guidewire could not travel further. Then the guidewire was inserted by the hub noticing an obstruction on the same area located 4cm from the hub proximal edge. The guidewire could not travel further than that point. The hub area that presents the obstruction was inspected with a vision observing that the guidewire hits with an unknown foreign material. A cross section cut was made to find out what is obstructing the guidewire lumen. As a result of the investigation one ptfe segment was found obstructing the lumen. According to the ft-ir analysis of the sample sent to the laboratory in a petri dish, the following infrared spectrum was obtained. Ftir analysis resulted, according to the spectra obtained both correspond to two types of polyamides and high-density polyethylene according to the functional groups present in each of the spectra obtained. A possible scenario for this defect to occur is that the use of mandrels in downstream processes could have caused an excessive friction that resulted in the eventual delamination of the inner layer. Once the inner layer was 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 accordion fashion, as observed in the complaint investigation. There are two possible scenarios for excessive friction of the mandrel: 1. - the tolerances of the od of the mandrel and the id of the inner body can cause an overlapping of these dimensions. Excessive friction can occur if a mandrel with od towards the upper end of the specification is used in a material extruded close to the id lower limit. 2. - use of a mandrel that has exceeded its useful life. Mandrels tend to bend and take an oscillating shape with use. Excessive friction can occur when using mandrels that are not completely straight. 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 82227857 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿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 accordion 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.

Event Description

As reported, a 2mm30cm 150 saber percutaneous transluminal angioplasty (pta) dilation catheter would not insert over an unknown wire. Another saber pta catheter was used to complete the procedure. There was no injury to the patient. Resistance was felt and the balloon was not able to be placed over the wire and was never used in the patient. The device was stored and prepped according to the instructions for use. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover, stylet or any of the sterile packaging components. No kinks or other damages were noted prior to use. The insertion difficulty was not caused by a blockage of possibly injectable material. The device is being returned for evaluation. Addendum: on product evaluation, the hub area that presents the obstruction was inspected with a vision system observing that the guidewire hits with an unknown foreign material. A cross section cut was made to find out what was obstructing the guidewire lumen, and as a result of the investigation one ptfe segment was found obstructing the lumen. Per analytical analysis results, the material found inside the complaint unit was positively identified as high-density polyethylene through ftir analysis. Then, it was concluded that there was no foreign material present in the unit.

• Brand Name: SABER 2MM30CM 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: 13759567
• MDR Text Key: 290083312
• Report Number: 9616099-2022-05452
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 48002030X
• Device Catalogue Number: 48002030X
• Device Lot Number: 82227857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/14/2022 Patient Sequence Number: 1

Treatment

UNK WIRE