MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER RX5MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.Please note that the catalog number of the reported device is not sold in the u.S.However, it is similar to other saber pta catheters that are sold in the u.S.
Event or Problem Description
A 5mm x 10cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at approximately nominal pressure during use.Therefore, it was replaced with a 6mm x 10cm x 155cm saber rx pta balloon and the procedure was completed.There was no reported patient injury.The lesion was the iliac artery which had a chronic total occlusion (cto).The device will not be returned for evaluation as it was discarded.
Additional Manufacturer Narrative
A 5mm x 10cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at approximately nominal pressure during use.Therefore, it was replaced with a 6mm x 10cm x 155cm saber rx pta balloon and the procedure was completed.There was no reported patient injury.The lesion was the iliac artery which had a chronic total occlusion (cto).The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82171800 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of chronic total occlusion may have contributed to the reported event.A chronically occluded vessel makes crossing into the lesion difficult; it is likely damage to balloon material occurred in the attempt to cross.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.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.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.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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 RX5MM10CM155
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 10817161
• Report Number: 9616099-2020-04045
• Device Sequence Number: 1768249
• Product Code: LIT
• UDI-Device Identifier: 20705032069929
• UDI-Public: 20705032069929
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/03/2020

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 51005010L
• Device Lot Number: 82171800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6X10X155 SABER RX PTA