MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002015X

Device Problems Partial Blockage (1065); Material Integrity Problem (2978)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, a non-cordis.018 guidewire was unable to pass through a 2mm x 15cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter while being pre-loaded outside of the patient.Additionally, it was reported there was difficulty experienced when attempting to flush the saber pta balloon catheter during preparation.As a result, a 2mm x 20cm 150cm saber pta balloon catheter was successfully used to complete the procedure and there was no reported injury to the patient.The 2mm x 15cm 150cm saber pta balloon catheter was prepped per the instructions for use (ifu) and there were no observed kinks to the device.The non-cordis guidewire that was used was not damaged in any way and was used successfully with other devices during this procedure.The target lesion was calcified and had a stenosis of 80%; however, there was no evidence of an acute angle or bifurcation present at the target site.Information regarding the target site, vessel tortuosity, and the possibility of an injectable obstruction was requested but not provided.The device was returned for analysis.A non-sterile saber 2mm 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.Per functional analysis, gw lumen flushing was intended to be performed; however, flushing could not be achieved.Next, an appropriate.018¿ lab sample guidewire was inserted via tip and vice versa, then via the hub with unsuccessful results.The guidewire could not entirely pass through the guidewire lumen of the unit.The guidewire was advanced and stopped at 52cm from the distal tip and no longer advanced as an obstruction was felt at this point.Per microscopic analysis, the unit was inspected under the vision system.It was confirmed that the.018¿ gw was stopped at the obstructed area at 52cm from the distal tip.The guidewire lumen was cut/dissected at the obstructed area and a piece of detached inner body polyethylene tucked inside the guidewire lumen was observed, the polyethylene was removed from the gw lumen.The polyethylene material was observed kind of accordioned (zigzag) inside the guidewire lumen and once removed, the material unraveled.The inner body of the unit was cut lengthwise near the obstructed area to obtain images of the possible damages at this affected area.Due to the observed damages in the interior of the inner body, sem analysis was performed.Results showed that the damaged area of the inner body of the saber 2mm x 15cm 150 unit presented evidence of polyethylene damages that could be caused by the cut performed on the inner body.However, evidence of scratches and deformations were noted on the lumen of the inner body.These damages could be caused by a rigid object that passed along the lumen of the unit.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 82221979 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 ¿guidewire lumen obstructed- during prep¿ was confirmed via device analysis.However, the exact cause cannot be determined.During analysis the material noted inside the guidewire lumen was noted to be 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.

Event Description

As reported, a non-cordis.018 guidewire was unable to pass through a 2mm x 15cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter while being pre-loaded outside of the patient.Additionally, it was reported there was difficulty experienced when attempting to flush the saber pta balloon catheter during preparation.As a result, a 2mm x 20cm 150cm saber pta balloon catheter was successfully used to complete the procedure and there was no reported injury to the patient.The 2mm x 15cm 150cm saber pta balloon catheter was prepped per the instructions for use (ifu) and there were no observed kinks to the device.The non-cordis guidewire that was used was not damage in any way and was used successfully with other devices during this procedure.The target lesion was calcified and had a stenosis of 80%; however, there was no evidence of an acute angle or bifurcation present at the target site.Information regarding the target site, vessel tortuosity, and the possibility of an injectable obstruction was requested but not provided, and the device will be returned for evaluation.Addendum: product evaluation on (b)(6) 2022 revealed a piece of detached inner body polyethylene tucked inside the guide wire lumen.

• Brand Name: SABER 2MM15CM 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: 14238306
• MDR Text Key: 290461830
• Report Number: 9616099-2022-05598
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069202
• UDI-Public: (01)20705032069202(17)240331(10)82221979
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48002015X
• Device Catalogue Number: 48002015X
• Device Lot Number: 82221979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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: 2MM X 20CM 150CM SABER PTA BALLOON CATHETER; V18 GUIDE WIRE (BOSTON SCIENTIFIC)
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG