MAUDE Adverse Event Report: CORDIS CASHEL SABER 8MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48008002S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17718394 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, an 8mm x 2cm 90 saber percutaneous transluminal angioplasty (pta) catheter was used for inflation of the lesion.It inflated at negative pressure when it was prepped.However, the air came out when it inflated at negative pressure.The doctor stopped using it.There was no patient injury reported.This was a pediatric percutaneous transluminal aortic valvuloplasty (ptav) case.The patient did not have an infectious disease.
Additional Manufacturer Narrative
An 8mm x 2cm x 90cm saber percutaneous transluminal angioplasty (pta) catheter was used for inflation of the lesion.It inflated at negative pressure when it was prepped.However, air came out when it inflated at negative pressure.The doctor stopped using it.There was no patient injury reported.This was a pediatric percutaneous transluminal aortic valvuloplasty (ptav) case.The patient did not have an infectious disease.The device was not returned for analysis.A product history record (phr) review of lot 17718394 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 negative prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely that handling of the product 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, ¿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 analysis results suggest that the reported event is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER 8MM2CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8829190
• Report Number: 9616099-2019-03098
• Device Sequence Number: 2337091
• Product Code: LIT
• UDI-Device Identifier: 20705032068885
• UDI-Public: 20705032068885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: 08/31/2020
• Device Model Number: 48008002S
• Device Catalogue Number: 48008002S
• Device Lot Number: 17718394
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1