MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM30CM 155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51002530L

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

As reported, the balloon of a 2.5mm x 30cm 155 saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured.As a result, the saberx pta balloon catheter was replaced with a non-cordis balloon which was used to complete the procedure.There was no reported patient injury.An ipsilateral approach was made with a 4.5f 55cm str non-cordis catheter sheath introducer (csi) to treat a lesion in the right anterior tibial artery, which was reported as having calcification and sever continuous stenosis.Two non-cordis guidewires were inserted past the target lesion, and the saberx pta balloon catheter was inserted and successfully inflated.During the second inflation of the saberx pta balloon catheter, the balloon ruptured within its nominal pressure.The device will not be returned for evaluation as it was discarded.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82165788 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h6, h10.The balloon of a 2.5mm x 30cm 155 saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured.As a result, the saberx pta balloon catheter was replaced with a non-cordis balloon which was used to complete the procedure.There was no reported patient injury.An ipsilateral approach was made with a 4.5f 55cm str non-cordis catheter sheath introducer (csi) to treat a lesion in the right anterior tibial artery, which was reported as having calcification and severe continuous stenosis.Two non-cordis guidewires were inserted past the target lesion, and the saberx pta balloon catheter was inserted and successfully inflated.During the second inflation of the saberx pta balloon catheter, the balloon ruptured within its nominal pressure.The product was not returned for analysis.A product history record (phr) review of lot 82184684 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 calcification and a severe rate of stenosis may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.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/preventive action will be taken at this time.

• Brand Name: SABER 2.5MM30CM 155
• 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: 13064098
• MDR Text Key: 283094436
• Report Number: 9616099-2021-05223
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075678
• UDI-Public: (01)20705032075678(17)220228(10)82165788
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 51002530L
• Device Lot Number: 82165788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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: BALLOON CATHETER (JADE, ORBUS NEICH); JUPITER FC1 GUIDEWIRE (BOSTON SCIENTIFIC); PROMINENT GUIDEWIRE (TOKAI MEDICAL PRODUCTS); SHEATH (4.5F55CM PARENT STR, TERUMO)