MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002515X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.It is unknown if the device will be returned for testing and evaluation.
Event or Problem Description
As reported, a 2.5mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter did not reach 4 atmospheres (atm).Initially, during material evaluation on the table, ¿the doctor noted a presence of saline solution jet in the distal area of the device¿.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 2.5mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter did not reach four atmospheres (atm).Initially, during material evaluation on the table, ¿the doctor noted a presence of saline solution jet in the distal area of the device¿.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 82183358 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 leakage¿ was not confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely vessel characteristics, handling of the device and procedural factors contributed to the reported event.However, based on the information provided and 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, ¿preparation 1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.
Additional Manufacturer Narrative
Product received on 21-jan-2021.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 Manufacturer Narrative
Complaint conclusion: as reported, a 2.5mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter did not reach four atmospheres (atm).Initially, during material evaluation on the table, ¿the doctor noted a presence of saline solution jet in the distal area of the device¿.There was no reported patient injury.One product was returned for analysis.One non-sterile saber 2.5mm x 15cm 150 balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon had been previously inflated.No anomalies could be observed at the naked eye.Functional test was intended to be performed on the unit.A syringe filled with water was attached to the inflation lumen and pressure was applied.However, a leakage was observed in the unit on the proximal section of the balloon area.Per microscopic analysis, sem analysis was performed to the received balloon unit to identify the possible root cause of the leakage condition on the balloon with the following results: results showed that the balloon leakage was caused by a rupture on the balloon surface.The external surface of the balloon presented evidence of abrasions and scratch marks near the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.Likely, the same factors that caused the observed abrasions and scratch marks on the balloon outer surface could have led to the rupture condition found on the received balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were found during the analysis.A product history record (phr) review of lot 82183358 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 leakage¿ was confirmed during device analysis.The exact cause cannot be determined.A leakage was confirmed through analysis of the returned device as a rupture was noted on the balloon surface.The outer surface of the balloon presented evidence of abrasions and scratch marks.It is likely vessel characteristics may have contributed to the reported event as evidenced by device analysis.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.According to the instructions for use, which are not intended to mitigate risk, ¿preparation 1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER 2.5MM15CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10896801
• Report Number: 9616099-2020-04082
• Device Sequence Number: 16867645
• Product Code: LIT
• UDI-Device Identifier: 20705032069066
• UDI-Public: 20705032069066
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2021

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: 11/30/2022
• Device Model Number: 48002515X
• Device Catalogue Number: 48002515X
• Device Lot Number: 82183358
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 01/21/2021; 02/23/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/09/2020; 02/16/2021; 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1