MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM25CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48002525S

Device Problem Leak/Splash (1354)

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

Event Date 02/11/2022

Event Type  malfunction  

Event Description

As reported, while flushing a 2.5mm 25cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter, leakage from a hole in the middle of the shaft of the saber pta balloon catheter was observed.There was no reported injury to the patient and the device will be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while flushing the guidewire lumen of a 2.5mm 25cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter during preparation, leakage from a hole in the middle of the shaft of the saber pta balloon catheter was observed.As a result, the 2.5mm 25cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter was not used, and an unknown balloon catheter was used to complete the procedure.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).Additional information was requested but was not provided, and the device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82186987 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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, while flushing the guidewire lumen of a 2.5mm 25cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter during preparation, leakage from a hole in the middle of the shaft of the saber pta balloon catheter was observed.As a result, the 2.5mm 25cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter was not used, and an unknown balloon catheter was used to complete the procedure.There was no reported injury to the patient.The device was prepped per the instructions for use (ifu).Additional information was requested but was not provided.The device was returned for analysis.A non-sterile saber 2.5mm x 25cm 90 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis of the body shaft, no anomalies could be observed at the naked eye.Per functional testing, a lab sample inflator/deflator device partially filled with water was attached to the inflation lumen of the unit and pressure was applied.The balloon was inflated as expected.Then, the lab sample inflator/ deflator device was attached to the guide wire thru lumen of the unit and positive pressure was applied.A leakage was observed coming from a rupture on the body shaft tack seal of the unit.No other anomalies were observed.Per sem analysis, results showed that the leakage on the body/shaft of the saber 2.5mm x 25cm 90 device presented evidence of a ruptured condition and scratch marks near the damaged area.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon could probably led to the damaged condition found on the received device.It seems the body/shaft material near the rupture was torn due to the interaction of the unit with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82186987 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 - during prep¿ was confirmed during functional analysis; however, the exact cause could not be determined.Device analysis revealed the body/shaft was torn and a leakage was noted from the torn area/tack seal section of the body/shaft upon functional analysis.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.According to the instructions for use, which are not intended to mitigate risk, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.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.¿ the product analysis suggests that the event experienced by the customer may be associated to the manufacturing process.Therefore, a risk assessment has been initiated for further investigation.

• Brand Name: SABER 2.5MM25CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13772551
• MDR Text Key: 290083074
• Report Number: 9616099-2022-05456
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032088489
• UDI-Public: (01)20705032088489(17)230228(10)82186987
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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 Catalogue Number: 48002525S
• Device Lot Number: 82186987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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
• Treatment: UNK BALLOON CATHETER.; UNK.