MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM25CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006025L

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82185366 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 Description

As reported, the balloon of a saber rx 6mm 25cm 155 ruptured during the second inflation while using for post dilation of two non-cordis stents.The saber rx was being used due to the blood vessel diameter being large.There was no reported injury to the patient.A cross-over approach was made.The lesion was the superficial femoral artery and back-knee.Two saber xs (2-300, 3-250) were used for back-knee.A saberx (5-250) was used as a percutaneous old balloon angioplasty (poba) for the superficial femoral artery.Two non-cordis stents were than implanted.The device will not be returned for evaluation.

Manufacturer Narrative

As reported, the balloon of a saber rx 6mm 25cm 155 ruptured during the second inflation while using for post dilation of two non-cordis stents.The saber rx was being used due to the blood vessel diameter being large.There was no reported injury to the patient.A cross-over approach was made.The lesion was the superficial femoral artery and back-knee.Two saberx¿s (2-300, 3-250) were used for back-knee.A saberx (5-250) was used as a percutaneous old balloon angioplasty (poba) for the superficial femoral artery.Two non-cordis stents were than implanted.Additional information was requested; however, the information was not obtained after multiple attempts.The device was not returned for evaluation.A product history record (phr) review of lot 82185366 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics and 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 safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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 25cm 155 ruptured during the second inflation while using for post dilation of two non-cordis stents.The saber rx was being used due to the blood vessel diameter being large.There was no reported injury to the patient.A cross-over approach was made.The lesion was the superficial femoral artery and back-knee.Two saber xs (2-300, 3-250) were used for back-knee.A saberx (5-250) was used as a percutaneous old balloon angioplasty (poba) for the superficial femoral artery.Two non-cordis stents were than implanted.The device will not be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.

• Brand Name: SABER RX6MM25CM155
• 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: 13999940
• MDR Text Key: 292841979
• Report Number: 9616099-2022-05505
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075319
• UDI-Public: (01)20705032075319(17)221231(10)82185366
• 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,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 51006025L
• Device Catalogue Number: 51006025L
• Device Lot Number: 82185366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Date Device Manufactured: 01/21/2020
• 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: SABERX (5-250).; TWO SABERXS (2-300, 3-250).; TWO STENTS (ELUVIA, BOSTON SCIENTIFIC).