MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51005030L

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

As reported, a 5mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was unable to cross a lesion and it was confirmed that the distal tip of the 5mm x 30cm 155cm saberx pta balloon catheter was frayed.As a result, the saberx pta balloon catheter was removed, and a non-cordis balloon catheter was successfully used without indication of damage to complete the procedure.There was no reported injury to the patient.This was during an endovascular therapy (evt) procedure in which the target lesion was the superficial femoral artery (sfa).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.The device was not kinked or damaged in any way prior to being inserted into the patient, and was not being used to treat a chronic total occlusion (cto).There was no resistance or friction experienced while inserting the balloon through the unknown catheter sheath introducer (csi).The balloon catheter was never in an acute bend, it was easily removed from the patient, and remained in one piece during removal.Prior to the attempted use of the 5mm x 30cm 155cm saberx pta balloon catheter, an unknown guidewire was able to be inserted past the target lesion.The same unknown guidewire was used throughout the entire procedure and there was no observed damage to that guidewire.An unknown, small-diameter balloon catheter was used successfully to pre-dilate the target lesion and there was no observed damage to this balloon catheter.Information regarding the level of calcification, level of tortuosity, percentage of stenosis, the csi used for the procedure, the guidewire used for the procedure, the balloon catheter used for pre-dilation, and the balloon catheter used to complete the procedure was requested but was not provided.The device was discarded and will not be returned for evaluation.

Manufacturer Narrative

As reported, a 5mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was unable to cross a lesion and it was confirmed that the distal tip of the 5mm x 30cm 155cm saberx pta balloon catheter was frayed.As a result, the saberx pta balloon catheter was removed, and a non-cordis balloon catheter was successfully used without indication of damage to complete the procedure.There was no reported injury to the patient.This was during an endovascular therapy (evt) procedure in which the target lesion was the superficial femoral artery (sfa).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.The device was not kinked or damaged in any way prior to being inserted into the patient and was not being used to treat a chronic total occlusion (cto).There was no resistance or friction experienced while inserting the balloon through the unknown catheter sheath introducer (csi).The balloon catheter was never in an acute bend, it was easily removed from the patient, and remained in one piece during removal.Prior to the attempted use of the 5mm x 30cm 155cm saberx pta balloon catheter, an unknown guidewire was able to be inserted past the target lesion.The same unknown guidewire was used throughout the entire procedure and there was no observed damage to that guidewire.An unknown, small-diameter balloon catheter was used successfully to pre-dilate the target lesion and there was no observed damage to this balloon catheter.Information regarding the level of calcification, level of tortuosity, percentage of stenosis, the csi used for the procedure, the guidewire used for the procedure, the balloon catheter used for pre-dilation, and the balloon catheter used to complete the procedure was requested but was not provided.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot 82221002 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system failure to cross¿ and ¿distal tip frayed/split/torn - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.Handling of the device, procedural factors, and vessel characteristics, although unknown, likely contributed to the reported events.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the safety information in the instructions for use ¿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.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.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.Always verify integrity of the catheter after removal.¿ neither the phr review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER RX5MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; juarez 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: 14022355
• MDR Text Key: 288837309
• Report Number: 9616099-2022-05523
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032076033
• UDI-Public: (01)20705032076033(17)240430(10)82221002
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51005030L
• Device Lot Number: 82221002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: NON-CORDIS BALLOON CATHETER; UNK BALLOON CATHETER; UNK GUIDEWIRE