MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER RX7MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51007004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, the balloon of a 7mm x 4cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at its nominal pressure.So, it was removed from the patient's body.There was no reported patient injury.The unknown stent was implanted at the superficial femoral artery (sfa).The lesion was severely calcified, with severe tortuosity.There was ninety percent stenosis.The device was used for a chronic total occlusion.The device was stored in the cardboard, in the cath lab.The device was stored, handled, and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop, or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There were no kinks, or other damages noted prior to inserting the product into the patient.The balloon catheter was removed easily and intact.The procedure was completed by using another device.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot#: 82191578 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 severe calcification and a chronic total occlusion may have contributed to the reported event as calcification is known to cause damage to balloon material.It is likely the balloon was damaged by calcification during delivery, or it may have been damaged by calcification during expansion.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 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.

Event Description

As reported, the balloon of a 7mm x 4cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at its nominal pressure.So, it was removed from the patient's body.There was no reported patient injury.The unknown stent was implanted at the superficial femoral artery (sfa).The lesion was severely calcified, with severe tortuosity.There was ninety percent stenosis.The device was used for a chronic total occlusion.The device was stored in the cardboard, in the cath lab.The device was stored, handled, and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There were no kinks, or other damages noted prior to inserting the product into the patient.The balloon catheter was removed easily and intact.The procedure was completed by using another device.Additional procedural details were requested but are unknown.The device will not be returned for evaluation as it was discarded.

• Brand Name: SABER RX7MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000 ; 7863138372
• MDR Report Key: 10943401
• MDR Text Key: 219512331
• Report Number: 9616099-2020-04096
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 51007004L
• Device Lot Number: 82191578
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Date Device Manufactured: 04/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN STENT