MAUDE Adverse Event Report: CORDIS US. CORP SABERX014; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	47560150M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 6mm x 150mm saber.014 percutaneous transluminal angioplasty (pta) balloon catheter ruptured.A non-cordis balloon was used as a replacement.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.1/3 contrast and 2/3 saline were used to prep the balloon.The target vessel was the superficial femoral artery (sfa).The target site vessel did not have calcification or tortuosity.The device will be returned 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
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the balloon of a 6mm x 150mm saber.014 percutaneous transluminal angioplasty (pta) balloon catheter ruptured.A non-cordis balloon was used as a replacement.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.One-third contrast and two-thirds saline were used to prep the balloon.The target vessel was the superficial femoral artery (sfa).The target site vessel did not have calcification or tortuosity.A non-sterile unit of ¿pta, rx, 6.0 x 150, 150cm¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.A thorough inspection was performed observing that the unit does not present any damages.The balloon arrived not inflated.No other outstanding details were observed.Functional test was performed.One inflator/deflator device was attached to the inflation port.Balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reaching the rate burst pressure (rbp).However, inflation pressure was not maintained due to a leak in the balloon caused by a rupture on the surface.The balloon was inspected with a vision system observing a rupture on the surface where the water was leaking.The balloon surface presented evidence of a rupture condition and secondary scratch marks located near the damaged border area.The failure reported by the customer as ¿balloon~burst¿ was confirmed, since a rupture condition was observed on the balloon surface that cause leaking, impeding maintenance of the inflation pressure.The exact cause of this condition observed on the balloon could not be conclusive determined during the analysis.Procedural factors and handling process may have contributed to the failure as reported.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface could probably led to the damaged condition found on the received device.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.The product analysis does not suggest that the observed damage could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

• Brand Name: SABERX014
• 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 ; 15th building smes venture park songshan lake hi-tech zone; dongguan, guangdong ; 7863138372
• MDR Report Key: 20334646
• Report Number: 1016427-2024-00033
• Device Sequence Number: 15478131
• Product Code: LIT
• UDI-Device Identifier: 20705032087572
• UDI-Public: (01)20705032087572(17)271231(10)2312040876
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 47560150M
• Device Lot Number: 2312040876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: .018 ABBOT BALLOON CATHETER.
• Patient Sex: Unknown