MAUDE Adverse Event Report: CORDIS CORPORATION SABER035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48007025R

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot# 82280775 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.

Event Description

As reported, a 7mm x 25cm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter would not thread onto a non-cordis guidewire and the non-cordis guidewire appeared to have protruded into the balloon lumen.This was after successfully inserting, inflating, and removing the saber.035 pta balloon catheter.As a result, a new 7mm x 40mm saber pta balloon catheter was used as a replacement without issue.There were no reported injuries to the patient.The device was stored, handled, and prepped correctly according to the instructions of use (ifu) prior to initial and second attempts to use the device.There was no difficulty removing any of the sterile packaging components.The device was prepped with a 50-50 contrast and saline mixture and maintained negative pressure during preparation.The device was initially inflated to 10 atmospheres (atm).There were no difficulties removing the device from the non-cordis guidewire after the first inflation.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, a 7mm x 25cm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter would not thread onto a non-cordis guidewire and the non-cordis guidewire appeared to have protruded into the balloon lumen.This was after successfully inserting, inflating, and removing the saber.035 pta balloon catheter.As a result, a new 7mm x 40mm saber pta balloon catheter was used as a replacement without issue.There were no reported injuries to the patient.The device was stored, handled, and prepped correctly according to the instructions of use (ifu) prior to initial and second attempts to use the device.There was no difficulty removing any of the sterile packaging components.The device was prepped with a 50-50 contrast and saline mixture and maintained negative pressure during preparation.The device was initially inflated to 10 atmospheres (atm).There were no difficulties removing the device from the non-cordis guidewire after the first inflation.The device was returned for analysis.One non-sterile unit of a saber.035 7x250 135cm sl was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.Per visual analysis, the balloon appears to have been previously inflated.The other components of the unit were inspected, and no anomalies were noted by the naked eye.Functional analysis was performed, first flushing was performed, and no anomalies nor difficulties were noted.Next, an insertion/withdrawal of an appropriate lab sample wire through the distal tip and the hub was attempted, and the wire presented resistance/friction on the inner lumen at the balloon area.Amplified image was taken, and a kink/bent condition was noted on the inner lumen causing the resistance felt.The balloon was inflated to determine if a possible leak or anomaly was noted since the customer reported a puncture; however, no anomalies were noted, the balloon inflated as expected.A product history record (phr) review of lot 82280775 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen obstructed¿ was confirmed via device analysis as a kink was noted on the inner lumen of the balloon area causing resistance with the guidewire.However, the reported ¿body/shaft puncture/cut¿ was not confirmed as no punctures or leaks were noted on the device during functional analysis.Therefore, based on the condition of the returned device and analysis findings, it is likely handling, and procedural factors not limited to; patient¿s anatomy, lesion¿s severity in calcification, stenosis and/or tortuosity may have contributed to the failure noted upon device analysis.The device was initially used successfully with no resistance/friction noted.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.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.Without twisting, slide the forming tube off the balloon.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.Place the prepared catheter over a prepositioned guidewire and advance the tip to the introduction site.Note: balloon inflation should be performed with the guidewire extended beyond the catheter tip.It is strongly recommended that the guidewire, the balloon catheter, or both, remain across the lesion until the procedure is complete and the dilatation system is to be removed from the vessel.Note: to preserve the folded balloon shape during insertion and catheter manipulation, maintain a vacuum on the inflation lumen.Caution: fully deflate the balloon by inducing negative pressure with the inflation system whenever the pta catheter is advanced or withdrawn.Do not advance or withdraw the pta catheter within the vasculature unless the catheter is preceded by a guidewire.Carefully advance the catheter through a sheath or guide catheter through the percutaneous entry site.Note: gentle counterclockwise rotation of the balloon may ease introduction through the sheath or percutaneous entry site.Note: perform all further catheter manipulations under fluoroscopy.Carefully advance the catheter to the selected stenosis.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.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: SABER035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 18767976
• MDR Text Key: 336879121
• Report Number: 3007635982-2024-00045
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 48007025R
• Device Lot Number: 82280775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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: 7MM X 40MM 035 SABER PTA BALLOON; MERIT SPLASH WIRE STIFF