MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at eight atm during its initial inflation. There was no reported injury to the patient. The case was completed after the use of an unknown device. It was noted that the balloon did not rupture while in the vessel. The product was stored properly according to the instructions for use (ifu). There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components. The device was prepped per the ifu. The device was prepped normally and was able to maintain negative pressure. The procedure being performed was an evt. The vessel was noted to have mild tortuosity and the lesion to have mild calcification. The lesion had a 90% stenosis. The device was not being used to treat a chronic total occlusion. An unknown guidewire crossed the lesion. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter. The device did not have any difficulty while advancing through the vessel or crossing the lesion. The device was never in acute bend and was never kinked while being used. The device was removed intact (in one piece) from the patient). The device was not returned for evaluation as the device was discarded. A product history record (phr) review of lot 82216448 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 stenosis and mild calcification likely contributed to the reported event, as calcification is known to damage balloon material. However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and 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 saber rx 6mm 4cm 155 ruptured at 8 atm during its initial inflation. There was no reported injury to the patient. The case was completed after the use of an unknown device. It was noted that the balloon did not rupture while in the vessel. The product was stored properly according to the instructions for use (ifu). There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components. The device was prepped per the ifu. The device was prepped normally and was sable to maintain negative pressure. The procedure being performed was an evt. The vessel was noted to have mild tortuosity and the lesion to have mild calcification. The lesion had a 90% stenosis. The device was not being used to treat a chronic total occlusion. A unknown guidewire cross the lesion. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. The device did not have any difficulty while advancing through the vessel or while crossing the lesion. The device was never in acute bend and was never kinked while being used. The device was removed intact (in one piece) from the patient). The device was discarded and will not be returned for evaluation.

• Brand Name: SABER RX6MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13977537
• MDR Text Key: 288385551
• Report Number: 9616099-2022-05499
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 51006004L
• Device Catalogue Number: 51006004L
• Device Lot Number: 82216448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/30/2021
• 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: 04/01/2022 Patient Sequence Number: 1

Treatment

UNK BALLOON CATH; UNK GUIDEWIRE