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

Catalog Number	48008010X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82207078 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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 opening the packaging for an 8mm x 10cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the distal balloon segment was found compressed.A non-cordis balloon catheter was used to continue the procedure.There were no reported injuries to the patient.This was during a procedure in which imaging showed a stenosis within the iliac artery which required balloon dilatation.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.There was no observed damage to the device packaging.The device has now been returned.Addendum: product evaluation revealed a leakage on the body/shaft of the device.
Additional Manufacturer Narrative
Complaint conclusion: as reported, after opening the packaging for an 8mm x 10cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the distal balloon segment was found compressed.A non-cordis balloon catheter was used to continue the procedure.There were no reported injuries to the patient.This was during a procedure in which imaging showed a stenosis within the iliac artery which required balloon dilatation.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.There was no observed damage to the device packaging.The device has now been returned.A non-sterile saber 8mm x 10cm 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, and no damage was observed during the unaided eye inspection.The balloon was received deflated.Per functional analysis, an inflator/deflator device was attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.During this test it was observed that the inflation/deflation mechanism was not working as intended as a leak was observed in the body/shaft of the device.Additionally, insertion/withdrawal testing was completed with no problems for resistance or friction conditions.Sem analysis was performed on the surface area where the leak was observed, and a puncture was noted along with scratch marks.The scratch marks observed in the surface area around the puncture identified may indicate the attributable cause for the damaged condition could be the interaction of the body shaft surface with a sharp object or mechanical damage.A product history record (phr) review of lot 82207078 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system compressed/crushed¿ was not confirmed as there were no signs of compression noted on the device; however, subsequent findings of ¿body/shaft leakage¿ were noted.Device analysis revealed a leakage coming from a punctured area on the external surface of the shaft during functional analysis.The outer surface of the shaft presented evidence of scratch marks near the puncture.This suggests the body/shaft puncture was caused by the interaction of the shaft material with a sharp object.Therefore, based on the information provided it is likely vessel characteristics of stenosis, may have contributed to the reported event it is likely damage to the shaft occurred in the attempt to cross into the lesion.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.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.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.¿ 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.

• 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: 18418665
• Report Number: 3007635982-2023-00356
• Device Sequence Number: 7846746
• Product Code: LIT
• UDI-Device Identifier: 20705032069745
• UDI-Public: (01)20705032069745(17)231031(10)82207078
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 48008010X
• Device Lot Number: 82207078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: CORDIS ANGIOGRAPHY CATHETER.; TERUMO GUIDEWIRE.; TERUMO VASCULAR SHEATH.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG