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

Catalog Number	48003025X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported a balloon leak was reported for the 0.18 saber 3mm x 25cm percutaneous transluminal angioplasty (pta) dilatation catheter.The anomaly was noted while inflating the device with positive pressure; leaking was found during filling.No balloon tear or pinhole was noted.The procedure was completed by changing to a new unknown balloon.There was no reported patient injury.The intended procedure was reported to be arteriosclerosis occlusion of the lower limbs.Vessel calcification was mild; there was no vessel tortuosity with seventy percent (70%) stenosis.The device was not used or a cto greater than three (3 months.The device was stored, handled, and prepped according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was no difficulty removing the product from the hoop or removing the protective balloon cover nor difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device maintained negative pressure during preparation.Contrast media was used and the contrast to saline ratio was 1:1.A pressure pump was used as inflation device and the same was successfully used with other devices.The gauge of the indeflator indicated a loss of pressure when the anomaly was noted.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82218442 presented no issues during the manufacturing process that could be related to the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported a balloon leak was reported for the 0.18 saber 3mm x 25cm percutaneous transluminal angioplasty (pta) dilatation catheter.The anomaly was noted while inflating the device with positive pressure; leaking was found during filling.No balloon tear or pinhole was noted.The procedure was completed by changing to a new unknown balloon.There was no reported patient injury.The intended procedure was reported to be arteriosclerosis occlusion of the lower limbs.Vessel calcification was mild; there was no vessel tortuosity with seventy percent (70%) stenosis.The device was not used or a cto greater than three months.The device was stored, handled, and prepped according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device maintained negative pressure during preparation.Contrast media was used and the contrast to saline ratio was 1:1.A pressure pump was used as inflation device and the same was successfully used with other devices.The gauge of the indeflator indicated a loss of pressure when the anomaly was noted.The device was returned for analysis.A non-sterile saber 3mm 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 no damages or anomalies were observed during the unaided eye visual inspection.The balloon was received deflated.Functional testing was performed, one inflator/deflator device was attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.A leak was observed in the body of the balloon.Sem analysis was performed to evaluate the surface of the balloon received.During sem analysis scratch marks were observed near the borders of the punctured balloon material.The scratch marks observed may be related to exposure of the external balloon surface to a sharp object.A product history record (phr) review of lot 82218442 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ was confirmed during functional analysis.However, the exact cause could not be determined.Sem analysis revealed scratch marks on the outer portion of the balloon and a leakage was noted coming from the body of the balloon.It appears the balloon was damaged by the interaction of the balloon material with a sharp object like calcified spicules located on the lesion or a mechanical damage.The vessel was described as stenotic with mild calcification; therefore, based on the analysis provided it is likely vessel characteristics contributed to the events reported.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 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 60th 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, costa rica ; 7863138372
• MDR Report Key: 17754915
• Report Number: 3007635982-2023-00297
• Device Sequence Number: 7209922
• Product Code: LIT
• UDI-Device Identifier: 20705032069127
• UDI-Public: 20705032069127
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 48003025X
• Device Lot Number: 82218442
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 11/10/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 09/28/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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: UNK BOCO GUIDEWIRE.; UNK TERUMO SHEATH.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 68 KG