MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48002515X

Device Problem Burst Container or Vessel (1074)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82189391 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, after the balloon of a 2.5mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter reached the working pressure of 8 atmospheres (atm); the user continue to pressurize to 10 atm and the balloon ruptured.Therefore, the device was replaced with another saber rx balloon catheter to complete the dilatation of the lesion.There was no reported patient injury.The target lesion/vessel was the left superficial femoral artery, with little calcification, no tortuosity and 100 percent stenosed.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device.There was no difficulty removing the product from the hoop, protective balloon cover, stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was opened in a sterile field.The device prepped normally.The customer used the balloon, ¿normal operation¿.The device was used in-conjunction with a non-cordis guidewire.The contrast to saline ratio was 1:1.A non cordis indeflator was used and was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve nor while inserting the balloon through the guide catheter.The balloon ruptured on it's first inflation.No unusual force was used at any time during the procedure.The device will be returned for evaluation.

Manufacturer Narrative

After the balloon of a 2.5mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter reached the working pressure of 8 atmospheres (atm); the user continues to pressurize to 10 atm and the balloon ruptured.Therefore, the device was replaced with another saber rx balloon catheter to complete the dilatation of the lesion.The target lesion/vessel was the left superficial femoral artery, with little calcification, no tortuosity and 100 percent stenosed.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device.There was no difficulty removing the product from the hoop, protective balloon cover, stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The device was opened in a sterile field.The device prepped normally.The customer used the balloon, ¿normal operation¿.The device was used in-conjunction with a non-cordis guidewire.The contrast to saline ratio was 1:1.A non-cordis indeflator was used and was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve nor while inserting the balloon through the guide catheter.The balloon ruptured on its first inflation.No unusual force was used at any time during the procedure.There was no reported patient injury.The device was returned for analysis as well as three pictures were received.A file with three pictures of a saber 2.5mm15cm 150, part number 48002515x, and lot number 82189391, was received for visual review attached to the complaint # (b)(4).Per visual analysis of the pictures attached to the complaint, it can be seen an empty packaging outer box with the information previously described in the label attached.In second picture, it can be observed what seems to be a rupture on a balloon.The third picture shows an inner pouch package containing a saber balloon.The device seems to be ruptured at the balloon area.Also, it can be observed that the inner pouch package containing the saber balloon device belongs to an unknown manufacturer hydrophilic wire.No other anomalies were observed.Even though, the balloon seems ruptured, the cause of the rupture observed could not be conclusively determined based on the pictures¿ visual analysis sole information provided.Therefore, the reported complaint by the customer as ¿balloon-burst - at/below rbp¿ was not confirmed at that time until the involved device was returned for a complete evaluation.Per visual analysis of the returned device, a 2.5mm x 15cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter involved in the complaint was received for analysis coiled inside a plastic bag.Per visual analysis, a rupture condition could be observed on the balloon of the unit.No other anomalies were observed.Per microscopic analysis, sem analysis was performed to the received balloon unit to identify the possible root cause of the rupture condition on the balloon with the following results: sem results showed that the external surface of the balloon showed evidence of abrasions, scratched marks, and peel-off material near to the rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.Likely, the same factors that caused the observed abrasions, scratched marks, and peel-off material on the balloon external surface could probably lead to the rupture condition found on the received balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.Neither evidence of damages was found on the analyzed proximal marker band.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.No other anomalies were found during the analysis.A product history record (phr) review of lot 82189391 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 ¿was confirmed due to the rupture condition on the balloon as received for analysis.However, the balloon presented evidence of abrasions, scratched marks, and peel-off material near to the balloon rupture area as observed, probably leading to the rupture found on the received unit.Nonetheless, the cause of the abrasions, scratched marks, and peel-off material could not be conclusively determined during the analysis.Moreover, it is probable that handling and procedural factors such as vessel characteristics of a chronic total occlusion (cto), 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 ¿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 review, device images nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SABER 2.5MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10968393
• MDR Text Key: 222306944
• Report Number: 9616099-2020-04104
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069066
• UDI-Public: 20705032069066
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 48002515X
• Device Catalogue Number: 48002515X
• Device Lot Number: 82189391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC CONTROL WIRE.; MERIT INDEFLATOR.
• Patient Age: 63 YR
• Patient Weight: 63