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

Catalog Number	R51005004L
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	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82246651 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during a radial peripheral case, a 6f 110cm brite tip radianz sheath prolapsed into the right atrium and coiled.The patient was briefly thrown into an arrythmia, but corrected once system was pulled out of right atrium.Once prolapse was corrected, it was discovered that the saberx radianz 5mm x 40mm balloon catheter was difficult to pull off the.018 non-cordis 300cm wire, the balloon broke off and fractured upon pulling out.The distal tip with radiopaque markers was still on the guidewire, which was snared from a left femoral access point using a non-cordis snare.The procedure was completed from a femoral access point, without patient injury or other incidents with a cordis product.
Event or Problem Description
As reported, during a radial peripheral case, a 6f 110cm brite tip radianz sheath prolapsed into the right atrium and coiled.The patient was briefly thrown into an arrythmia, but corrected once system was pulled out of right atrium.Once prolapse was corrected, it was discovered that the saberx radianz 5mm x 40mm balloon catheter was difficult to pull off the.018 non-cordis 300cm wire, the balloon broke off and fractured upon pulling out.The distal tip with radiopaque markers was still on the guidewire, which was snared from a left femoral access point using a non-cordis snare.The procedure was completed from a femoral access point, without patient injury or other incidents with a cordis product.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Additional Manufacturer Narrative
During a radial peripheral case, a 6f 110cm brite tip radianz sheath prolapsed into the right atrium and coiled.The patient was briefly thrown into an arrythmia, but corrected once system was pulled out of right atrium.Once prolapse was corrected, it was discovered that the saberx radianz 5mm x 40mm balloon catheter was difficult to pull off the.018 non-cordis 300cm wire, the balloon broke off and fractured upon pulling out.The distal tip with radiopaque markers was still on the guidewire, which was snared from a left femoral access point using a non-cordis snare.The procedure was completed from a femoral access point, without patient injury or other incidents with a cordis product.Additional information and device return was requested; however, both were not obtained after multiple attempts made.The product was not returned for analysis.A product history record (phr) review of lot 82246651 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¿ and ¿arrhythmia¿ could not be confirmed as the device was not returned for analysis, nor were procedural images provided for review.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event, such as placing the sheath in the right atrium.According to the warnings in the safety information in 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.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.¿ neither the phr review nor the information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABERX RADIANZ
• 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: 17939814
• Report Number: 3007635982-2023-00317
• Device Sequence Number: 6455537
• Product Code: LIT
• UDI-Device Identifier: 20705032081679
• UDI-Public: (01)20705032081679(17)250331(10)82246651
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201377
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 03/31/2025
• Device Catalogue Number: R51005004L
• Device Lot Number: 82246651
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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: 110CM RADIANZ SHEATH; 300CM .018 BOSTON SCIENTIFIC V18; CORDIS BRITE TIP RADIANZ 6F 110CM; CORDIS SABERX 6MM X 40MM; MERIT ENSNARE
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White