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

Catalog Number	48004010X
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number is unknown additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the bottom balloon portion on a 4mm x 10cm saber percutaneous transluminal angioplasty (pta) balloon catheter detached at its connection point and flipped inside out during removal from the body.The balloon appeared to have gotten caught up on a 6f non-cordis sheath during removal; however, the balloon was removed in its entirety.There were no reported injuries to the patient.An antegrade approach was used for this procedure.The balloon was inflated and deflated three times without issue prior to the detachment of the distal balloon section.The proximal balloon section remained attached.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d9, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the bottom balloon portion on a 4mm x 10cm saber percutaneous transluminal angioplasty (pta) balloon catheter detached at its connection point and flipped inside out during removal from the body.The balloon appeared to have gotten caught up on a 6f non-cordis sheath during removal; however, the balloon was removed in its entirety.There were no reported injuries to the patient.An antegrade approach was used for this procedure.The balloon was inflated and deflated three times without issue prior to the detachment of the distal balloon section.The proximal balloon section remained attached.The device was not returned as expected.Without the return of the device or images for analysis, the reported customer events ¿balloon- withdrawal difficulty¿ and ¿balloon- frayed/split/torn¿ could not be confirmed.Procedural or handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of 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.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).Never use air or any gaseous medium to inflate the balloon.¿ 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.¿ 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.
Event or Problem Description
As reported, the bottom balloon portion on a 4mm x 10cm saber percutaneous transluminal angioplasty (pta) balloon catheter detached at its connection point and flipped inside out during removal from the body.The balloon appeared to have gotten caught up on a 6f non-cordis sheath during removal; however, the balloon was removed in its entirety.There were no reported injuries to the patient.An antegrade approach was used for this procedure.The balloon was inflated and deflated three times without issue prior to the detachment of the distal balloon section.The proximal balloon section remained attached.Additional information was requested but was not provided.The device was not returned as expected.

• Brand Name: SABER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 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: 19633282
• Report Number: 3007635982-2024-00167
• Device Sequence Number: 12930078
• Product Code: LIT
• UDI-Device Identifier: 20705032069479
• UDI-Public: 20705032069479
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Device Catalogue Number: 48004010X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: .018 COMMAND WIRE; 6 FR PINNACLE BY TERUMO
• Patient Sex: Unknown