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

Model Number	48005020X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the first saber 6 x 20 balloon was stuck on the unknown wire.Multiple flushes did not solve problem.A second saber 5 x20 did not deflate after initial inflation.Dr.Had to pull into sheath with negative pressure to get balloon out.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the first saber 6 x 20 balloon was stuck on the unknown wire.Multiple flushes did not solve problem.A second saber 5 x20 did not deflate after initial inflation.Dr.Had to pull into sheath with negative pressure to get balloon out.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Additional Manufacturer Narrative
After further review of additional information received the following sections have as reported, the first saber 6 x 20 balloon was stuck on the unknown wire.Multiple flushes did not solve problem.A second saber 5 x20 did not deflate after initial inflation.Dr.Had to pull into sheath with negative pressure to get balloon out.There was no reported injury to the patient.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 82246643 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen resistance/friction¿ and ¿balloon deflation difficulty unable to¿ were not confirmed as the devices were not returned for analysis.The exact cause could not be determined.Use of the device with the concomitant hydrophilic wire may have been a contributing factor; additionally, the contrast to saline ratio used was not provided.Little procedural details were provided; therefore, based on the information provided and without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the devices and the reported events.It is likely procedural factors and handling of the device may have contributed to the event reported by the customer.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.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.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.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.¿ 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.
Additional Manufacturer Narrative
As reported, the first saber 6 x 20 balloon was stuck on the unknown wire.Multiple flushes did not solve problem.A second saber 5 x20 did not deflate after initial inflation.Dr.Had to pull into sheath with negative pressure to get balloon out.There was no reported injury to the patient.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 82246643 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen resistance/friction¿ and ¿balloon deflation difficulty unable to¿ were not confirmed as the devices were not returned for analysis.The exact cause could not be determined.Use of the device with the concomitant hydrophilic wire may have been a contributing factor; additionally, the contrast to saline ratio used was not provided.Little procedural details were provided; therefore, based on the information provided and without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the devices and the reported events.It is likely procedural factors and handling of the device may have contributed to the event reported by the customer.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.Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.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.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.¿ 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 first saber 6 x 20 balloon was stuck on the unknown wire.Multiple flushes did not solve problem.A second saber 5 x20 did not deflate after initial inflation.Dr.Had to pull into sheath with negative pressure to get balloon out.There was no reported injury to the patient.Additional information and device return was requested; however, both were not obtained after multiple attempts made.

• 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: 17004192
• Report Number: 3007635982-2023-00191
• Device Sequence Number: 6343569
• Product Code: LIT
• UDI-Device Identifier: 20705032069554
• UDI-Public: (01)20705032069554(17)250430(10)82246643
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

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: 04/30/2025
• Device Model Number: 48005020X
• Device Catalogue Number: 48005020X
• Device Lot Number: 82246643
• 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: 05/25/2023; 05/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/09/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2022
• 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: NO INFORMATION AVAILABLE.
• Patient Sex: Unknown