• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51007004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2022
Event Type  malfunction  
Manufacturer Narrative
During use of the saber percutaneous transluminal angioplasty (pta) rx 7mm x 4cm155 balloon catheter, the balloon would not inflate after crossing the lesion. There was no patient injury. The saber was replaced with another saber and the procedure was completed. There was no difficulty noted in the balloon during prep. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product into the patient. This was a "vaivt" case. The lesion was the shunt just above the venous anastomosis, which was stenosed ninety percent, severely tortuous and mildly calcified. An approach was made from an artery and a guidewire (0. 014) crossed the lesion. The saber pta was used. The saber balloon crossed the lesion and was attempted to be inflated as first inflation, but it was unable to be inflated. A competitor's contrast media and inflation device was used with a contrast to saline ratio of 50:50. The inflation device was successfully used with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter. The catheter has never been in an acute bend. The product removed intact (in one piece) from the patient with no damages noted to the balloon. The saber balloon was replaced with another same sized saber rx and the procedure completed. There was a possibility of leaking. No other information was provided. The product was returned for analysis. A non-sterile saber rx 7mm x 4cm 155 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag. Per visual analysis, no physical characteristics were observed by the naked eye. Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied. A balloon leakage was observed on the proximal area of the balloon. No other anomalies were observed. Per microscopic analysis, sem analysis was performed, results showed that the balloon leakage was caused by a puncture. The inner surface presented no anomalies near the balloon damage. The outer surface presented evidence of scratch marks near the balloon puncture. This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage. It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface probably led to the ruptured condition found on the received device. It seems the balloon material near the rupture was damaged 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 observed during the sem analysis. A product history record (phr) review of lot 82216944 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst¿ was confirmed via device analysis as a leakage was noted on the proximal section of the balloon surface due to a puncture. However, the exact cause cannot be determined. The outer surface of the balloon presented evidence of scratch marks adjacent to the balloon rupture. It is likely vessel characteristics of 90% stenosis, severe tortuosity, and calcification contributed to the reported event as evidenced by device analysis. The balloon material near the rupture, appears to have been punctured 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. The procedure performed was a shunt venous anastomosis, arteriovenous shunts are often scarred and fibrous in nature and are therefore, often resistant to balloon expansion increasing the likelihood of damage to the balloon. According to the warnings in the safety information in the instructions for use ¿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
During use of the saber percutaneous transluminal angioplasty (pta) rx 7mm4cm155 balloon catheter, the balloon would not inflate after crossing the lesion. Additional information was received and during functional test of the received balloon system by fal a balloon leakage was observed on the proximal area of the balloon. Results showed that the balloon leakage was caused by a puncture. There was no patient injury. The saber was replaced with another saber and the procedure was completed. There was no difficulty noted in the balloon during prep. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. This was a "vaivt" case. The lesion was the shunt just above the venous anastomosis which was stenosed ninety percent, severely tortuous and mildly calcified. An approach was made from an artery and a guidewire (0. 014) crossed the lesion. The saber pta was used. The saber balloon crossed the lesion and was attempted to be inflated as first inflation but it was unable to be inflated. A competitor's contrast media and inflation device was used with a contrast to saline ratio of 50:50. The inflation device was successfully used with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter. The catheter has never been in an acute bend. The product removed intact (in one piece) from the patient with no damages noted to the balloon. The saber balloon was replaced with another same sized saber rx and the procedure completed. There was a possibility of leaking. The device will be returned for analysis. No other information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER RX7MM4CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th avenue
miami lakes, FL 33014
7863138372
MDR Report Key14043695
MDR Text Key290463428
Report Number9616099-2022-05527
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51007004L
Device Catalogue Number51007004L
Device Lot Number82216944
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/07/2022 Patient Sequence Number: 1
Treatment
IOPAMIDOL; MEDTRONI; SABERX; UNK GUIDEWIRE (0.014)
-
-