MAUDE Adverse Event Report: CORDIS CORPORATION SABER 4MM10CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48004010S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 4mm x 10cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter had contrast media leakage from its proximal shaft part that was confirmed.Therefore, it was replaced with a same size new unknown balloon catheter and the procedure was completed.There was no reported patient injury.This was a shunt pta case.Multiple attempts were made without success to obtain the device.Additional information was requested but was not obtained.The device was not returned for evaluation.A product history record (phr) review of lot 82189387 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft leakage - in-patient¿ was not confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely vessel characteristics, although unknown, and/or procedural factors may have contributed to the reported event.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.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.
Event or Problem Description
As reported, a 4mm x 10cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter, however, contrast media leakage was confirmed from its proximal shaft part.Therefore, it was replaced with a same size new unknown balloon catheter and the procedure was completed.There was no reported patient injury.This was a shunt pta case.Multiple attempts were made without success to obtain the device.Additional information was requested but was not obtained.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a 4mm x 10cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter had contrast media leakage from its proximal shaft part that was confirmed.Therefore, it was replaced with a same size new unknown balloon catheter and the procedure was completed.There was no reported patient injury.This was a shunt pta case.Multiple attempts were made without success to obtain the device.Additional information was requested but was not obtained.The device was returned for evaluation.A non-sterile 4mm x 10cm 90 saber percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the unit was thoroughly inspected, and no anomalies found.Functional analysis was performed; a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen and positive pressure was applied to the unit.The unit was inflated, and pressure was maintained as expected.No anomalies found.A product history record (phr) review of lot 82189387 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft leakage - in-patient¿ was not confirmed during device analysis.The exact cause cannot be determined.It is likely procedural factors or handling of the product may have contributed to the reported event.The device passed functional analysis and performed as intended.Therefore, it is difficult to draw a clinical conclusion between the device and the event reported as no anomalies were noted to the device.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 4MM10CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12362282
• Report Number: 9616099-2021-04810
• Device Sequence Number: 17096756
• Product Code: LIT
• UDI-Device Identifier: 20705032069783
• UDI-Public: (01)20705032069783(17)230228(10)82189387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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: 02/28/2023
• Device Model Number: 48004010S
• Device Catalogue Number: 48004010S
• Device Lot Number: 82189387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/24/2021; 11/08/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/19/2021; 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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
• Patient Sex: Unknown