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

Model Number 51007004L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: goodman nse balloon catheter, goodman nse balloon catheter, smart stent.A device history record (dhr) review of lot 82156642 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a saber rx 7mm x 4cm 155 percutaneous transluminal angioplasty (pta) balloon catheter (bc) balloon ruptured when it attempted to cross the lesion due to severe calcification.There was no reported patient injury.The lesion was the iliac artery which had stenosis.An ipsilateral approach was made.It was replaced with a non-cordis bc which also ruptured.Another non-cordis bc was used and a smart stent was implanted and the procedure was completed.

Manufacturer Narrative

Complaint conclusion: a saber rx 7mm x 4cm 155cm percutaneous transluminal angioplasty (pta) balloon catheter (bc) balloon ruptured when it attempted to cross the lesion due to severe calcification.There was no reported patient injury.The lesion was the iliac artery which had stenosis.An ipsilateral approach was made.It was replaced with a non-cordis bc which also ruptured.Another non-cordis bc was used and a smart stent was implanted, and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 82156642 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 of severe calcification and stenosis may have contributed to the reported event, as severe calcification is known to damage balloon material.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 RX7MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8586074
• MDR Text Key: 144268426
• Report Number: 9616099-2019-02904
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 51007004L
• Device Catalogue Number: 51007004L
• Device Lot Number: 82156642
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1