MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM2CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002002X

Device Problems Partial Blockage (1065); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while performing preconditioning testing for saber over the wire (otw), an obstruction of foreign material was found inside of the guidewire lumen of a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter.As mentioned, this was during preconditioning testing of the device and there was no patient involvement or clinical use of the device.The sample was successfully flushed; however, during the guidewire insertion portion of the sample prep, the guidewire failed to pass through the lumen and out of the hub.Upon review of the device, an obstruction was seen in the lumen near the hub.An inflation device with filtered water was then used to flush the injection lumen.I was reported that 30 atmospheres (atm) of pressure was required to dislodge the obstructing material from the balloon catheter.The device along with the obstructing material was sent to the analytical lab for further analysis.

Manufacturer Narrative

Health effect - clinical code of 4581 - "appropriate term / code not available" was used to code "pre-market testing".The devices associated with lot number: 82230564 were not meant for market use.A review of the manufacturing documentation associated with lot 82230564 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.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

Complaint conclusion: as reported, while performing preconditioning testing for saber over the wire (otw), an obstruction of foreign material was found inside of the guidewire lumen of a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter.As mentioned, this was during preconditioning testing of the device and there was no patient involvement or clinical use of the device.The sample was successfully flushed; however, during the guidewire insertion portion of the sample prep, the guidewire failed to pass through the lumen and out of the hub.Upon review of the device, an obstruction was seen in the lumen near the hub.An inflation device with filtered water was then used to flush the injection lumen.I was reported that 30 atmospheres (atm) of pressure was required to dislodge the obstructing material from the balloon catheter.The device was returned for analysis.A non-sterile saber 2mm x 2cm 150 percutaneous transluminal angioplasty (pta) balloon catheter along with a petri box was received for analysis coiled inside a plastic bag.Per visual analysis, the strain relief of the unit could be observed moved out of position.Also, a little piece of inner body polyethylene material was received inside the previous mentioned petri box.No other anomalies found.Also, it was stated that ¿per microscopic analysis, ftir was performed on the little piece of foreign material found in the saber otw.Based on the ftir results, the material resembles polyethylene¿.A product history record (phr) review of lot 82230564 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 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 2MM2CM 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: 13904804
• MDR Text Key: 290463093
• Report Number: 9616099-2022-05487
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069196
• UDI-Public: (01)20705032069196(17)240731(10)82230564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48002002X
• Device Catalogue Number: 48002002X
• Device Lot Number: 82230564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: UNK GUIDEWIRE.