MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX2MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51002010L

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82185301 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 2mm x 10cm 155cm saber rapid exchange (rx) was attempted to be removed from the patient after it inflated the lesion, however, there was a stronger resistance felt between the non-cordis sheath and the saber device.The physician kept withdrawing but it got separated at the part where 4 cm before the 40 cm exit port at the distal end.The part(s) remained in the patient were on the non-cordis guidewire, therefore, they were attempted to be removed.The doctor cut near the tip of the kink.The non-cordis guidewire was withdrawn a little and the part(s) remained in the patient were withdrawn together.The physician kept withdrawing it and they were removed from the patient.There has been no reported patient injury after the procedure.There were no abnormalities on the saber device prior to using on the procedure.This was an endovascular therapy (evt) case.The lesion was the lower limb artery.An ipsilateral antegrade approach was made with a 4fr 10cm non-cordis sheath.A non-cordis guidewire crossed the lesion.It was mentioned that since a z-shaped kink was found on the non-cordis guidewire, which was outside the patient¿s body from the reverse blood valve of the sheath, it was difficult to insert other devices.The separated fragment(s) will probably be returned together.The non-cordis sheath, non-cordis guidewire and the saber device will be returned for analysis.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The device did not kink or bend at any time prior to the resistance/friction.There were no kinks/bends noted after the resistance/friction was experienced.There was difficulty tracking through the vasculature.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The target lesion was the lower leg artery with little calcification.There was moderate vessel tortuosity/angulation.The device will be returned for analysis.

Manufacturer Narrative

As reported, the 2mm x 10cm 155cm saber rapid exchange (rx) was attempted to be removed from the patient after it inflated the lesion; however, there was a stronger resistance felt between the non-cordis sheath and the saber device.The physician kept withdrawing but it got separated at the part where 4 cm before the 40 cm exit port at the distal end.The part(s) remained in the patient were on the non-cordis guidewire, therefore, they were attempted to be removed.The doctor cut near the tip of the kink.The non-cordis guidewire was withdrawn a little and the part(s) remained in the patient were withdrawn together.The physician kept withdrawing it and they were removed from the patient.There has been no reported patient injury after the procedure.The target lesion was the lower leg artery with little calcification.There was moderate vessel tortuosity/angulation.There were no abnormalities on the saber device prior to using on the procedure.This was an endovascular therapy (evt) case.The lesion was the lower limb artery.An ipsilateral antegrade approach was made with a 4fr 10cm non-cordis sheath.A non-cordis guidewire crossed the lesion.It was mentioned that since a z-shaped kink was found on the non-cordis guidewire, which was outside the patient¿s body from the reverse blood valve of the sheath, it was difficult to insert other devices.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The device did not kink or bend at any time prior to the resistance/friction.There were no kinks/bends noted after the resistance/friction was experienced.There was difficulty tracking through the vasculature.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.One product was returned for analysis.A non-sterile saber rx 2mm x 10cm 155 balloon catheter along with an unknown guide wire and an unknown sheath introducer was received for analysis inside a plastic bag.The accompanying sheath introducer was observed twisted damaged as well as the concomitant guide wire was received kinked/ bent at the soft tip end.Per visual analysis, the saber unit was received body shaft separated.The body shaft separation was located at 50.3 cm from the distal portion of the unit.The balloon of the saber was inspected under the vision system and it had been previously inflated.Also, dried blood residues could be observed on the unit received.No other anomalies found.Per microscopic analysis, the saber unit was observed under the vision system and the body shaft separation showed that the unit presented evidence of elongations at the separated area.The elongations found on the body/shaft of the unit are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the body shaft material yield strength prior to the separation.No other anomalies were found during the analysis.Per dimensional analysis, the balloon proximal seal of the unit was measured and found within specifications.A product history record (phr) review of lot 82185301 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿distal tip separated - in-patient¿ and ¿pta/ptca system withdrawal difficulty - through guide/sheath¿ was confirmed by device analysis due to the severely damaged body/shaft and separated condition of the unit received.The body/shaft presented evidence of elongations at the separated area during analysis of the device.However, the exact cause of the damages noted cannot be determined.The elongations found on the body/shaft of the unit are commonly associated with separations caused by material tensile overload.These elongations suggest that the separated area was induced to stretching/pulling events that exceeded the material yield strength prior to the separation.Therefore, procedural and handling factors likely contributed to the reported event.According to the safety information in the instructions for use ¿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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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 RX2MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10382314
• MDR Text Key: 202171829
• Report Number: 9616099-2020-03836
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 51002010L
• Device Lot Number: 82185301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (ASAHI INTECC); SHEATH (4FR 10CM TERUMO)
• Patient Outcome(s): Required Intervention