MAUDE Adverse Event Report: CORDIS CASHEL SABER RX2MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51002004L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17661083 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, a 2mmx4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated to the right posterior tibial artery (rpta), however, it ruptured at approximately 10 atmospheres (atm) during its second inflation.Therefore, it was replaced with a new same size non-cordis balloon catheter and the procedure was completed.There was no reported patient injury.The device will not be returned for evaluation as it was discarded.The target lesion was the right posterior tibial artery and the popliteal artery.The lesion had severe calcification and stenosis.An ipsilateral approach was made with a non-cordis guiding sheath.A non-cordis micro-catheter and a non-cordis guidewire were able to cross the lesion.A non-cordis balloon catheter was inserted and inflated for the popliteal artery.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, and h6 have been updated accordingly.A 2mm x 4cm x 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated to the right posterior tibial artery (rpta); however, it ruptured at approximately ten atmospheres (atm) during its second inflation.The target lesion was the right posterior tibial artery and the popliteal artery.The lesion had severe calcification and stenosis.Therefore, it was replaced with a new same size non-cordis balloon catheter and the procedure was completed.There was no reported patient injury.An ipsilateral approach was made with a non-cordis guiding sheath.A non-cordis micro-catheter and a non-cordis guidewire were able to cross the lesion.A non-cordis balloon catheter was inserted and inflated for the popliteal artery.Additional procedural details were requested but unknown.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17661083 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 severe calcification with stenosis may have 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.

• Brand Name: SABER RX2MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9532372
• MDR Text Key: 199865881
• Report Number: 9616099-2019-03442
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 51002004L
• Device Catalogue Number: 51002004L
• Device Lot Number: 17661083
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER (4MM*4CM NSE, GOODMAN); BALLOON CATHETER (JADE, ORBUS NEICH); GUIDEWIRE (JUPITER FC1, BOSTON SCIENTIFIC); GUIDING SHEATH (4.5F 55CM STR PARENT, MEDKIT); MICRO CATHETER (PROMINENT, TOKAI MEDICAL PRODUCTS)