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

Catalog Number	48002520X
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a.018 saber 2.5mmx20cm 150cm percutaneous transluminal angioplasty (pta) balloon catheter had difficulty in withdrawing post dilatation use.After further investigation, it was found that the balloon seemed to have "dislodged" from its original position and was missing one of the markers.The marker was left inside the patient and retrieval was not attempted as it was difficult to see.The device was able to cross the lesion, but not easily.The device was difficult to remove after inflation.The device was removed with the unknown wire as it was not able to be retrieved over the wire.The device was removed from the patient, but the marker was left behind.There was no reported patient injury.There was no difficulty removing the protective balloon cover.There was no difficulty removing any of the sterile packaging components.An antegrade approach was used was used in the procedure.The target vessel was not heavily calcified, not tortuous and no acute or bifurcating angles.The stenosis was severe near the occlusion.A non-cordis long sheath was used to reach the popliteal artery.Accessing the target vessel, it was not calcified, tortuous, had no stenosis nor bifurcating acute angles.Device remained deflated during prep.The device was not put into an acute bend at any point during the procedure.The device did not kink at any time during the procedure.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There were no anomalies noted while inflating the device with positive pressure.There were no anomalies with the gauge of the indeflator that indicated a loss of pressure.Pressure was maintained, and deflation was normal.There was no leakage observed during deflation of the balloon.There was no stent used.The user states that "that the balloon was potentially slightly longer than what he wanted to use".The non-cordis sheath looked ok upon retrieval.Co2 was used as contrast media for this procedure.The device will be returning for evaluation.
Additional Manufacturer Narrative
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
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
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, a.018 saber 2.5mmx20cm 150cm percutaneous transluminal angioplasty (pta) balloon catheter had difficulty in withdrawing post dilatation use.After further investigation, it was found that the balloon seemed to have "dislodged" from its original position and was missing one of the markers.The marker was left inside the patient and retrieval was not attempted as it was difficult to see.The device was able to cross the lesion, but not easily.The device was difficult to remove after inflation.The device was removed with the unknown wire as it was not able to be retrieved over the wire.The device was removed from the patient, but the marker was left behind.There was no reported patient injury.There was no difficulty removing the protective balloon cover or any of the sterile packaging components.An antegrade approach was used in the procedure.The target vessel was not heavily calcified, not tortuous and no acute or bifurcating angles.The stenosis was severe near the occlusion.A non-cordis long sheath was used to reach the popliteal artery.Accessing the target vessel, it was not calcified, tortuous, had no stenosis nor bifurcating acute angles.Device remained deflated during prep.The device was not put into an acute bend at any point during the procedure.The device did not kink at any time during the procedure.The contrast to saline ratio was 50/50.The same indeflator was used successfully with other devices.There were no anomalies noted while inflating the device with positive pressure.There were no anomalies with the gauge of the indeflator that indicated a loss of pressure.Pressure was maintained, and deflation was normal.There was no leakage observed during deflation of the balloon.There was no stent used.The user states that "that the balloon was potentially slightly longer than what he wanted to use".The non-cordis sheath looked ok upon retrieval.Co2 was used as contrast media for this procedure.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device was returned for evaluation.A non-sterile ¿saber 2.5mm20cm 150¿ was received coiled inside of a clear plastic bag.The product was unpacked from the pouch for evaluation.The balloon and wire lumen were received with the distal section separated, but the separated pieces were not included for analysis.The two marker bands were not mounted on the inner lumen inside the balloon.Due to the nature of the complaint, a functional analysis related to the difficulty of withdrawing the balloon from the vessel was not performed as this cannot be replicated in a lab setting.Inspection of the separated area with a vision system revealed elongations, scratches, and plastic deformations on both edges.These findings are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the device was subjected to a tensile force that exceeded the material¿s yield strength before the separation.No other anomalies were observed during the evaluation.The reported ¿balloon withdrawal difficulty-from vessel¿ was not confirmed as this event reported cannot be properly evaluated in a lab setting due to the nature of the complaint.Several factors can contribute to withdrawal difficulties such as patient anatomy, operator technique and appropriate device selection.Additionally, there was some difficulty noted when crossing the lesion.However, the device was received separated and in very poor condition suggesting it was induced to events exceeding it material yield strength.The reported ¿balloon separated" and ¿marker band dislodged¿ were confirmed, the distal section of the balloon and the balloon inner wire lumen were separated and not returned for analysis.The two marker bands were loose inside the balloon not mounted on the inner lumen.The exact causes of the observed damages could not be conclusive determined during the analysis.Inspection of the separated area with a vision system revealed elongations, scratches, and plastic deformations on both edges.Based on the information available for review, vessel characteristics, procedural factors and handling of the device likely contributed to the events reported as evidence by analysis of the returned device.As stated in the event description it was noted the contrast agent used during the procedure was co2.This is prohibited according to the instructions for use and is listed in the warnings in the ifu as such.According to the warnings in the safety information in the instructions for use, ¿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.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.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).According to the safety information of the instructions for use ¿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.¿ the information available, the product analysis, and the condition of the returned device does not suggest that the issue reported could be related to the design or manufacturing process of the unit.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 19747263
• Report Number: 3007635982-2024-00184
• Device Sequence Number: 15704428
• Product Code: LIT
• UDI-Device Identifier: 20705032069073
• UDI-Public: (01)20705032069073(17)270228(10)82308095
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 48002520X
• Device Lot Number: 82308095
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 08/15/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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: 50/50 CONTRAST RATIO; 5F DESTINATION LONG SHEATH; CO2; UNKNOWN WIRE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 83 KG