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

Model Number	48003525X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, after inflation of a 3.5mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the balloon could not be easily deflated.An attempt to re-dilate the balloon was made, however; the balloon could not be fully inflated.Despite the difficulty deflating the balloon, the balloon was eventually deflated, and the device was withdrawn along an unknown guidewire.A 3.5mm x 20cm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a 75% occlusion of the p3 segment within the popliteal artery which was visualized during angiography.The lesion showed no signs of calcification or tortuosity.An antegrade approach was made from the right femoral artery for this procedure.The device was stored and prepared per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.There was no difficulty removing the stylet or any of the sterile packaging components.The balloon was initially inflated to 15 atmospheres (atm).The device was remained in one piece during its removal.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: complaint conclusion: as reported, after inflation of a 3.5mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the balloon could not be easily deflated.An attempt to re-dilate the balloon was made, however; the balloon could not be fully inflated.Despite the difficulty deflating the balloon, the balloon was able to be fully deflated after repeatedly inflating and deflating the balloon, and the device was then withdrawn along an unknown guidewire.A 3.5mm x 20cm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a 75% occlusion of the p3 segment within the popliteal artery which was visualized during angiography.The lesion showed no signs of calcification or tortuosity.An antegrade approach was made from the right femoral artery for this procedure.The device was stored and prepared per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.There was no difficulty removing the stylet or any of the sterile packaging components.The balloon was initially inflated to 15 atmospheres (atm).The device was remained in one piece during its removal.The device will be returned for evaluation.The product was returned for analysis.A non-sterile saber 3.5mm x 25cm 150 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that it does not present any damages or anomalies.The balloon was received deflated.Functional testing was performed, a syringe was attached to the inflation lumen to simulate the inflation mechanism.The balloon did not show any type of anomaly or defect that impeded the correct inflation.Deflation was then executed, and the balloon was completed deflated to its original state.The insertion of the corresponding guidewire was tested, and no issues were observed during the passthrough of the wire.A product history record (phr) review of lot 82234615 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - partial or slow¿ and ¿balloon deflation difficulty¿ were not confirmed through analysis of the returned device.The exact cause of the reported events could not be determined as the device passed functional analysis and insertion/withdrawal testing of the guidewire lumen.The balloon was inflated/deflated without any issues noted to the balloon catheter or balloon material.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies for inflation/deflation were noted on the device during functional testing.According to the safety information of the instructions for use ¿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.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82234615 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.
Event or Problem Description
As reported, after inflation of a 3.5mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the balloon could not be easily deflated.An attempt to re-dilate the balloon was made, however; the balloon could not be fully inflated.Despite the difficulty deflating the balloon, the balloon was able to be fully deflated after repeatedly inflating and deflating the balloon, and the device was then withdrawn along an unknown guidewire.A 3.5mm x 20cm non-cordis balloon catheter was used to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a 75% occlusion of the p3 segment within the popliteal artery which was visualized during angiography.The lesion showed no signs of calcification or tortuosity.An antegrade approach was made from the right femoral artery for this procedure.The device was stored and prepared per the instructions for use (ifu) and maintained negative pressure during preparation.The balloon was prepped with a 1:1 contrast to saline ratio.There was no difficulty removing the stylet or any of the sterile packaging components.The balloon was initially inflated to 15 atmospheres (atm).The device was remained in one piece during its removal.The device will be returned for evaluation.

• 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; el coyol alajuela bld 25 33014 ; 7863138372
• MDR Report Key: 16930494
• Report Number: 3007635982-2023-00181
• Device Sequence Number: 20543363
• Product Code: LIT
• UDI-Device Identifier: 20705032069400
• UDI-Public: (01)20705032069400(17)240930(10)82234615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• 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,Followup
• Report Date (Section B): 09/20/2023

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: 09/30/2024
• Device Model Number: 48003525X
• Device Catalogue Number: 48003525X
• Device Lot Number: 82234615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 09/11/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/12/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2021
• 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: 3.5MM X 20CM BALLOON CATHETER (BOSTON); TRAILBLAZER CATHETER; V-18 GUIDEWIRE; VERTEBRAL ARTERY CATHETER
• Patient Sex: Unknown