MAUDE Adverse Event Report: CORDIS CORPORATION SABER035 9MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48009004N

Device Problem Defective Component (2292)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the marker bands of a 0.035¿ 9mm x 4cm x 80cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) lacks visibility.The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement.There was no reported patient injury.The saber was not exposed to long periods of sunlight in the receiving area.The humidity was not controlled in this room.The saber was stored there for around 2 days before it was distributed to the cath lab.The saber was not exposed to long periods of sunlight, high temperatures or increased humidity at any time prior to use in the cath lab.The balloon cover/sheath and shipping stylet were removed separately.There was no damage noted to the product¿s packaging prior to opening.There were no anomalies noted when the saber was removed from its packaging.There were no kinks noted on the device in the affected region.The intended procedure was an iliac procedure.The lesion was moderately calcified.There was no vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was stored and handled per the instruction for use (ifu).There was no difficulty removing the product from the hoop.There was difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).An indeflator inflation device was used.The same indeflator was used successfully with other devices.There was resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The catheter was not torqued against resistance.The catheter was not re-shaped by the user.The product was removed intact (in one piece) from the patient.All the marker bands were accounted for after removal of the device.

Manufacturer Narrative

Complaint conclusion: as reported, the marker bands of a 0.035¿ 9mm x 4cm x 80cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) lacks visibility.The procedure was completed normally, but with a poor visibility of the marker bands, having a negative impact on the accuracy of the balloon placement.There was no reported patient injury.The saber was not exposed to long periods of sunlight in the receiving area.The humidity was not controlled in this room.The saber was stored there for around 2 days before it was distributed to the cath lab.The saber was not exposed to long periods of sunlight, high temperatures or increased humidity at any time prior to use in the cath lab.The balloon cover/sheath and shipping stylet were removed separately.There was no damage noted to the product¿s packaging prior to opening.There were no anomalies noted when the saber was removed from its packaging.There were no kinks noted on the device in the affected region.The intended procedure was an iliac procedure.The lesion was moderately calcified.There was no vessel tortuosity.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was stored and handled per the instruction for use (ifu).There was no difficulty removing the product from the hoop.There was difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).An indeflator inflation device was used.The same indeflator was used successfully with other devices.There was resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The catheter was not torqued against resistance.The catheter was not re-shaped by the user.The product was removed intact (in one piece) from the patient.All the marker bands were accounted for after removal of the device.The device was not returned for analysis.A product history record (phr) review of lot 82195452 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band-balloon catheters inadequate radiopacity, packaging/ pouch/box removal difficulty - protective balloon cover (balloon catheters) and pta/ptca system resistance/friction-outer body¿ could not be confirmed as the device was not returned for analysis.Nor were procedural images provided for review.The exact cause could not be determined.Possible causes of the reported events may include how the device was prepped, procedural factors such as fluoroscopy settings, and/or vessel characteristics.However, without the return of the device for analysis, or images of the reported inadequate radiopacity, it is not possible to draw a clinical conclusion between the device and the events reported by the customer.According to the device description in the safety information in the instructions for use ¿the cordis saber¿.035 percutaneous transluminal angioplasty (pta) catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths 100mm or greater, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.Saber balloons are coated with a hydrophilic material designed to increase lubricity throughout the lifetime of the device.The radiopaque marker bands indicate the stated nominal length of the balloon.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¿.The root cause could not be conclusively determined as the device was not returned for analysis.However, it appears the balloon cover removal difficulty may be related to the manufacturing process of the product.Therefore, a risk assessment to address this issue has been initiated.

• Brand Name: SABER035 9MM4CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11273582
• MDR Text Key: 230262446
• Report Number: 9616099-2021-04232
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 48009004N
• Device Catalogue Number: 48009004N
• Device Lot Number: 82195452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1