MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006020X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82186295 presented no issues during the manufacturing process that could be related to the reported event.The device was received for evaluation but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the distal tip of a 6mm x 20cm150 saber percutaneous transluminal angioplasty (pta) balloon separated inside the patient.The user did not notice the broken catheter distal tip while using the balloon catheter; however, later during the procedure, aspiration was required, and the distal end of the saber balloon catheter was retrieved.There was no reported patient injury.The intended procedure was reported to be a percutaneous transluminal angioplasty (pta).There was moderate vessel tortuosity and calcification.The percentage stenosis is unknown; it is also unknown if the device was being used for a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu).There was no device damage noticed prior to opening the package.There was no difficulty removing the product from the hoop or removing the protective balloon cover nor difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.There was no resistance/friction while inserting the balloon into the patient or difficulty advancing the balloon catheter through the vessel nor difficulty crossing the lesion.The balloon catheter did not kink while being used.The distal tip was retrieved intact (in one piece) by aspiration.The patient was not hospitalized because of the event.Neither the product nor any of the other devices used with it had been re-sterilized.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.
Additional Manufacturer Narrative
After further review of additional information received.Complaint conclusion: as reported, the distal tip of a 6mm x 20cm150 saber percutaneous transluminal angioplasty (pta) balloon separated inside the patient.The user did not notice the broken catheter distal tip while using the balloon catheter; however, later during the procedure, aspiration was required, and the distal end of the saber balloon catheter was retrieved.There was no reported patient injury.The intended procedure was reported to be a percutaneous transluminal angioplasty (pta).There was moderate vessel tortuosity and calcification.The percentage stenosis is unknown; it is also unknown if the device was being used for a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu).There was no device damage noticed prior to opening the package.There was no difficulty removing the product from the hoop or removing the protective balloon cover nor difficulty removing the stylet or any of the sterile packaging components.No kinks or other damages were noted prior to inserting the product into the patient.There was no resistance/friction while inserting the balloon into the patient or difficulty advancing the balloon catheter through the vessel nor difficulty crossing the lesion.The balloon catheter did not kink while being used.The distal tip was retrieved intact (in one piece) by aspiration.The patient was not hospitalized because of the event.Neither the product nor any of the other devices used with it had been re-sterilized.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device, in addition to images was returned for analysis.Per image analysis, shows a pouch of a saber pta dilatation catheter, lot 82186295, catalogue number 48006020x is noted.An apparent distal tip separated is noted.One non-sterile unit of a saber 6mm20cm 150 was received inside of a clear plastic bag and was unpacked to proceed with the product evaluation.Per visual analysis, the balloon was received partially inflated, it cannot be established at naked eye if the distal tip is separated, however it seems like it (looks shorter than expected).No other anomalies were noted on the device as received.Per sem analysis results showed that the separation on the distal tip of the device presented evidence of elongations and a possible incomplete/partial fusion between the materials of the tip.The elongations found on the material of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the distal tip was induced to a tensile force that exceeded the material yield strength prior to the separation.However, due the incomplete/partial fusing process between the materials, the material yield strength could be lower than the presented with a complete fusion.Nevertheless, the exact cause of the separation could not be determined during analysis.No other anomalies were observed during the sem analysis.A product history review of lot 82186295 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip ¿ separated¿ was confirmed since the device did not present the distal tip as received.The soft tip was dimensionally measured, and it was found below the tolerance accepted for the component, thus the separation/component missing was confirmed.Further inspection using vision system observed no evidence of heat applied to the transition between the distal tip and the tip seal melt zone.The product analysis suggests that the event experienced by the customer could be related to the manufacturing process.This event has been escalated via the risk management process and an investigation has been opened to address the issue.
Additional Manufacturer Narrative
The device was received for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SABER 6MM20CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 16350773
• Report Number: 9616099-2023-06251
• Device Sequence Number: 6836638
• Product Code: LIT
• UDI-Device Identifier: 20705032069639
• UDI-Public: (01)20705032069639(17)230131(10)82186295
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 48006020X
• Device Catalogue Number: 48006020X
• Device Lot Number: 82186295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 03/15/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/07/2023; 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown