MAUDE Adverse Event Report: CORDIS US. CORP SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002020X
Medical Device Problem Codes	Partial Blockage (1065); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to track towards a calcified superficial femoral artery (sfa) lesion as it entered the patient along a non-cordis.018 guidewire.There was also difficulty removing the saber pta balloon catheter which required the balloon catheter and non-cordis guidewire to be removed together.As a result, a new 2mm x 2cm 150cm saber pta balloon catheter was used to complete the procedure.There was no reported injury to the patient.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the stylet or any of the sterile packaging components.A contralateral approach was used for this procedure, and it was reported that an inflation of 8 atmospheres (atm) was made with the balloon within the popliteal artery prior to the resistance experienced.The balloon was fully deflated prior to removing the device and the device was able to be removed in one piece.The device will be returned for evaluation.Addendum: the 2mm x 2cm 150cm saber pta balloon catheter was returned in two separate pieces.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82246679 presented no issues during the manufacturing process that can be related to the reported event.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.
Additional Manufacturer Narrative
Complaint conclusion: a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to track towards a calcified superficial femoral artery (sfa) lesion as it entered the patient along a non-cordis.018 guidewire.There was also difficulty removing the saber pta balloon catheter which required the balloon catheter and non-cordis guidewire to be removed together.As a result, a new 2mm x 2cm 150cm saber pta balloon catheter was used to complete the procedure.There was no reported injury to the patient.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the stylet or any of the sterile packaging components.A contralateral approach was used for this procedure, and it was reported that an inflation of 8 (eight) atmospheres (atm) was made with the balloon within the popliteal artery prior to the resistance experienced.The balloon was fully deflated prior to removing the device and the device was able to be removed in one piece.The product was returned for analysis.A non-sterile saber 2mm x 20cm 150cm pta balloon catheter was received coiled inside of a clear plastic bag.Per visual analysis the device was segmented in the distal portion of the device, and the balloon was not received for analysis.Per functional analysis a lab sample guidewire test was introduced, and two obstructions were observed along the guidewire lumen located 47.2 cm and 76 cm from the more distal segmented end of the device as received.Per sem analysis the segmented section was analyzed to identify a possible root cause for the separations observed.The separations observed in the body shaft of the device analyzed presented evidence of elongations in the borders of these separations that were observed to have an incisive elongation direction, along with scratches.These observed conditions on the plastic materials of the unit are commonly associated with events where material is exposed to a shear overloading stress, and to the presence of sharp materials that were in contact with the body shaft surface.Therefore, it is assumed that the unit was induced to a shear stress using a sharp material.No other anomalies were observed during the sem analysis.Per ftir analysis of the white matter retrieved from the affected zones of the guide wire lumen the ir spectrum shows characteristic peaks suggestive of polyethylene composition, and as biological residues composition, due to the observed absorbance characteristic for amides, lipids, carbohydrates, and phospholipids.A product history record (phr) review of lot 82246679 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen- resistance/friction¿, ¿guidewire lumen - obstructed - particles/material can be injected¿ and ¿body/shaft-separated¿ were confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by abrasions noted on the outer surface during analysis.According to 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.Flush the ¿thru¿ lumen with sterile heparinized saline or a similar isotonic solution.According to the instructions for use, which are not intended to mitigate risk, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.¿ however, the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was unable to track towards a calcified superficial femoral artery (sfa) lesion as it entered the patient along a non-cordis.018 guidewire.There was also difficulty removing the saber pta balloon catheter which required the balloon catheter and non-cordis guidewire to be removed together.As a result, a new 2mm x 2cm 150cm saber pta balloon catheter was used to complete the procedure.There was no reported injury to the patient.The device was stored, handled, and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the stylet or any of the sterile packaging components.A contralateral approach was used for this procedure, and it was reported that an inflation of 8 atmospheres (atm) was made with the balloon within the popliteal artery prior to the resistance experienced.The balloon was fully deflated prior to removing the device and the device was able to be removed in one piece.The device will be returned for evaluation.Addendum: the 2mm x 2cm 150cm saber pta balloon catheter was returned in two separate pieces and the device was obstructed by the guidewire lumen.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17286620
• Report Number: 3007635982-2023-00231
• Device Sequence Number: 11509401
• Product Code: LIT
• UDI-Device Identifier: 20705032069219
• UDI-Public: (01)20705032069219(17)250531(10)82246679
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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 Expiration Date: 05/31/2025
• Device Model Number: 48002020X
• Device Catalogue Number: 48002020X
• Device Lot Number: 82246679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABBOT .018 GUIDEWIRE; COOK SHEATH; TEMPO PUNCTURE KIT; UNK GUIDEWIRE
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian