MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51005004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: unknown 6f guiding sheath; unknown guidewire (0.014); unknown balloon catheter (2mm x 4cm); abbott jackal 5mm x 4cm balloon catheter.Complaint conclusion: a saber rx 5mm x 4cm 155cm percutaneous transluminal angioplasty (pta) balloon catheter (bc) that ruptured within its nominal pressure.There was no reported patient injury.The target lesion was the left superficial femoral artery which had stenosis.The lesion had severe calcification and there was moderate vessel tortuosity.An approach was made from the right inguinal region and a 6f guiding sheath was inserted.A guidewire (0.014¿) crossed the lesion and a balloon catheter (2mm x 4cm) was inserted and inflated as pta.The saber was replaced with a new, same sized non-cordis bc and the procedure was completed.The physician was unclear if the balloon rupture was caused by a malfunction of the device or the calcification of the vessel.There was not any vessel angulation.The device was stored and handled per the instructions for use (ifu).There was not any difficulty removing the product from the hoop.There was not any difficulty removing the protective balloon cover.There was not any difficulty removing the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was not any resistance or friction while inserting the balloon through a y connector.There was not any guiding catheter used.There was not any difficulty advancing the balloon catheter through the vessel.There was a little difficulty crossing the lesion.The catheter was never in an acute bend.The balloon was inflated once.The device was removed intact (in one piece) from the patient.The product was not returned for analysis.A product history record (phr) review of lot 17623151 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.Without the return of the product for analysis it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics such as severe calcification and procedural factors may have contributed to the reported event.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.

Event Description

As reported, a saber rx 5mmx4cm 155 percutaneous transluminal angioplasty (pta) balloon catheter (bc) that ruptured within its nominal pressure.There was no reported patient injury.The target lesion was the left superficial femoral artery which had stenosis.An approach was made from the right inguinal region and a 6f guiding sheath was inserted.A guidewire (0.014) crossed the lesion and a balloon catheter (2mm x 4cm) was inserted and inflated as pta.The saber was replaced with a new, same sized non-cordis bc and the procedure was completed.The physician was unclear if the balloon rupture was caused by a malfunction of the device or the calcification of the vessel.The device has been discarded by the hospital.The lesion had severe calcification.There was moderate vessel tortuosity.There was not any vessel angulation.The device was stored and handled per the instructions for use (ifu).There was not any difficulty removing the product from the hoop.There was not any difficulty removing the protective balloon cover.There was not any difficulty removing the stylet or any of the sterile packaging components.There were not any kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.The same indeflator was used successfully with other devices.There was not any resistance or friction while inserting the balloon through a y connector.There was not any guiding catheter used.There was not any difficulty advancing the balloon catheter through the vessel.There was a little difficulty crossing the lesion.The catheter was never in an acute bend.The balloon was inflated once.The device was removed intact (in one piece) from the patient.

• Brand Name: SABER RX5MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8469322
• MDR Text Key: 140534351
• Report Number: 9616099-2019-02815
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 51005004L
• Device Catalogue Number: 51005004L
• Device Lot Number: 17623151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2016
• 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