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

Catalog Number 51006025L

Device Problem Leak/Splash (1354)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis, but the engineering report is not yet available.

Event Description

As reported, a 6mm x 25cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used; however, when it was inflated at 3 atmospheres (atm), the contrast media splattered from the shaft to the hand side.It was judged that the shaft of the ¿contrast media lumen¿ got broken.It was then removed from the body and was replaced with a new 6mm balloon catheter (unknown) to complete the procedure.There was no reported patient injury.The lesion was the superficial femoral artery (sfa).A guidewire (unknown) crossed the lesion and a 5mm x 25mm saber rx pta balloon catheter was inflated as pre-dilation.After that, a non-cordis stent was implanted.The device will be returned for evaluation.

Manufacturer Narrative

As reported, a 6mm x 25cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used; however, when it was inflated at 3 atmospheres (atm), the contrast media splattered from the shaft to the hand side.It was judged that the shaft of the ¿contrast media lumen¿ got broken.It was then removed from the body and was replaced with a new 6mm balloon catheter (unknown) to complete the procedure.There was no reported patient injury.The lesion was the superficial femoral artery (sfa).A guidewire (unknown) crossed the lesion and a 5mm x 25mm saber rx pta balloon catheter was inflated as pre-dilation.After that, a non-cordis stent was implanted.The device was returned for analysis.A non-sterile saber rx 6mm x 25cm 155 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a plastic bag.Per visual analysis, the unit was inspected, and no anomalies could be observed.Functional analysis was performed on the unit; a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.A leakage due to rupture on the body shaft of the unit was observed at 60.5 cm from the distal tip.Per sem analysis, results showed that the torn body/shaft was caused by a rupture on the body/shaft area.The outer surface presented evidence of scratch marks near the body/shaft area rupture.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft area surface may have led to the rupture condition found on the received device.It seems the body/shaft material near the rupture was torn either due to the interaction of the body/shaft with calcified spicules located on the lesion or with a sharp object from the outside of the body/shaft.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 ¿body/shaft leakage - in-patient¿ was confirmed during functional analysis.The exact cause could not be determined.Device analysis revealed the body/shaft was torn and a leakage was noted from the torn area upon functional analysis.The outer surface of the shaft presented evidence of scratch marks near the torn area.Based on the information provided it appears the body/shaft leakage was caused by the interaction of the shaft material with a sharp object.It is likely vessel characteristics, although unknown, may have contributed to the reported event as calcification can damage the body/shaft material.According to the instructions for use, which are not intended to mitigate risk, ¿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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ 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 RX6MM25CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12514206
• MDR Text Key: 272978502
• Report Number: 9616099-2021-04887
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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 Catalogue Number: 51006025L
• Device Lot Number: 82185366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SABERX (5MM*25MM); STENT (6MM ELUVIA, BOSTON SCIENTIFIC); UNKNOWN GUIDEWIRE