MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX3MM6CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51003006L

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

As reported, a 3mm x 6cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used to treat a severely calcified, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) when the balloon ruptured during an inflation of 3 to 6 atmospheres (atm).The 3mm x 6cm 155cm saberx pta balloon catheter was removed and another 3mm x 6cm 155cm saberx pta balloon catheter was inserted and successfully inflated to 6 to 8 atmospheres (atm).A 6mm x 25cm saber pta balloon catheter was then used to further dilate the lesion followed by a three minute inflation with a 6mm x 15cm non-cordis drug-coated balloon catheter, and a three minute inflation with a 6mm x 12cm non-cordis drug-coated balloon catheter.There was no reported issue while using the non-cordis drug-coated balloons catheters.After the use of the non-cordis drug-coated balloon catheters, it was reported that "dissociation" was confirmed at the sfa; however, no injury to the sfa was reported.A 7mm x 8cm s.M.A.R.T.Self-expanding stent (ses) was then implanted in the sfa, and the procedure was completed without injury to the patient.The target vessel was reported as moderately tortuous and an ipsilateral approach was used for the procedure with a 6f 28cm non-cordis catheter sheath introducer (csi).The saberx pta balloon catheter was prepped according to the instructions for use (ifu), the device maintained negative pressure during preparation, and there was no difficulty experienced while removing any of the sterile packaging components.Iopamidol 370 contrast was used for the procedure.There was no resistance or friction experienced while inserting the balloon into the patient.The balloon was able to track through the vessel and cross the target lesion with ease, and the balloon catheter was never in an acute bend.An.014 190cm g14 vassallo guidewire was used for the procedure along with an.014 235cm floppy vassallo guidewire.Two non-cordis guidewires were also used during this procedure.All four of the guidewires were able to cross the lesion, and none of the four guidewires reportedly used in this procedure were found to be damaged.The 3mm x 6cm 155cm saberx pta balloon catheter was removed easily from the patient and remained in one piece during removal.Information regarding the contrast to saline ratio, inflation pressure of the drug-coated balloons, and current patient status 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 82182426 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, a 3mm x 6cm 155cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter was being used to treat a severely calcified, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) when the balloon ruptured during an inflation of 3 to 6 atmospheres (atm).The 3mm x 6cm 155cm saber rx pta balloon catheter was removed and another 3mm x 6cm 155cm saber rx pta balloon catheter was inserted and successfully inflated to 6 to 8 atmospheres (atm).A 6mm x 25cm saber pta balloon catheter was then used to further dilate the lesion followed by a three-minute inflation with a 6mm x 15cm non-cordis drug-coated balloon catheter, and a three-minute inflation with a 6mm x 12cm non-cordis drug-coated balloon catheter.There was no reported issue while using the non-cordis drug-coated balloons catheters.After the use of the non-cordis drug-coated balloon catheters, it was reported that "dissociation" was confirmed at the sfa; however, no injury to the sfa was reported.A 7mm x 8cm s.M.A.R.T.Self-expanding stent (ses) was then implanted in the sfa, and the procedure was completed without injury to the patient.The target vessel was reported as moderately tortuous, and an ipsilateral approach was used for the procedure with a 6f 28cm non-cordis catheter sheath introducer (csi).The saber rx pta balloon catheter was prepped according to the instructions for use (ifu), the device maintained negative pressure during preparation, and there was no difficulty experienced while removing any of the sterile packaging components.Lopamidol 370 contrast was used for the procedure.There was no resistance or friction experienced while inserting the balloon into the patient.The balloon was able to track through the vessel and cross the target lesion with ease, and the balloon catheter was never in an acute bend.An.014 190cm g14 vassallo guidewire was used for the procedure along with an.014 235cm floppy vassallo guidewire.Two non-cordis guidewires were also used during this procedure.All four of the guidewires were able to cross the lesion, and none of the four guidewires reportedly used in this procedure were found to be damaged.The 3mm x 6cm 155cm saber rx pta balloon catheter was removed easily from the patient and remained in one piece during removal.Information regarding the contrast to saline ratio, inflation pressure of the drug-coated balloons, and current patient status was requested but was not provided.The device was returned for analysis.A non-sterile saber rx 3mm x 6cm155 percutaneous transluminal angioplasty (pta) was received for analysis inside a plastic bag.Per visual analysis, no anomalies could be observed at the naked eye.Per functional analysis, a lab sample inflator/ deflator device partially filled with water was attached to the inflation lumen of the saber and pressure was applied.The balloon of the unit was able to be inflated.No anomalies on the balloon of the unit were found.However, a leakage was observed on the body shaft of the unit near to the guidewire exit port zone.No other anomalies were observed.Per microscopic analysis, sem analysis was performed to the received saber unit, results showed a ruptured area of the device, with evidence of scratch marks near the ruptured area on the guidewire exit port zone.It seems the material near the rupture was torn 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 82182426 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 ¿balloon- burst - at/below rbp ¿was not confirmed during analysis of the returned device as no anomalies were observed on the balloon and it performed as intended during functional analysis.However, a ¿body/shaft- burst¿ was observed on the body shaft of the unit near the guidewire exit port.The exact cause for the issue could not conclusively be determined, however it is likely vessel characteristics such as a chronic total occlusion and moderate tortuosity with a cross-over approach may have contributed to the reported event.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.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, product analysis, 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.

Event Description

As reported, a 3mm x 6cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used to treat a severely calcified, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa) when the balloon ruptured during an inflation of 3 to 6 atmospheres (atm).The 3mm x 6cm 155cm saberx pta balloon catheter was removed and another 3mm x 6cm 155cm saberx pta balloon catheter was inserted and successfully inflated to 6 to 8 atmospheres (atm).A 6mm x 25cm saber pta balloon catheter was then used to further dilate the lesion followed by a three minute inflation with a 6mm x 15cm non-cordis drug-coated balloon catheter, and a three minute inflation with a 6mm x 12cm non-cordis drug-coated balloon catheter.There was no reported issue while using the non-cordis drug-coated balloons catheters.After the use of the non-cordis drug-coated balloon catheters, it was reported that "dissociation" was confirmed at the sfa; however, no injury to the sfa was reported.A 7mm x 8cm s.M.A.R.T.Self-expanding stent (ses) was then implanted in the sfa, and the procedure was completed without injury to the patient.The target vessel was reported as moderately tortuous and an ipsilateral approach was used for the procedure with a 6f 28cm non-cordis catheter sheath introducer (csi).The saberx pta balloon catheter was prepped according to the instructions for use (ifu), the device maintained negative pressure during preparation, and there was no difficulty experienced while removing any of the sterile packaging components.Iopamidol 370 contrast was used for the procedure.There was no resistance or friction experienced while inserting the balloon into the patient.The balloon was able to track through the vessel and cross the target lesion with ease, and the balloon catheter was never in an acute bend.An.014 190cm g14 vassallo guidewire was used for the procedure along with an.014 235cm floppy vassallo guidewire.Two non-cordis guidewires were also used during this procedure.All four of the guidewires were able to cross the lesion, and none of the four guidewires reportedly used in this procedure were found to be damaged.The 3mm x 6cm 155cm saberx pta balloon catheter was removed easily from the patient and remained in one piece during removal.Information regarding the contrast to saline ratio, inflation pressure of the drug-coated balloons, and current patient status was requested but was not provided, and the device will be returned for evaluation.Addendum: product evaluation revealed that the body/shaft of the 3mm x 6cm 155cm saberx pta balloon catheter had ruptured.

• Brand Name: SABER RX3MM6CM155
• 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: 13789469
• MDR Text Key: 291239023
• Report Number: 9616099-2022-05460
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075746
• UDI-Public: (01)20705032075746(17)221031(10)82182426
• 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,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 51003006L
• Device Lot Number: 82182426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• 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: .014 190CM G14 VASSALLO GUIDEWIRE, GW1419G14; .014 235CM FLOPPY VASSALLO GUIDEWIRE, VGW1423FL0; 3MM X 6CM 155CM SABERX PTA BALLOON CATHETER; 6MM X 25CM SABER PTA BALLOON CATHETER; 7MM X 8CM S.M.A.R.T. SELF-EXPANDING STENT (SES); COMMANDO GUIDEWIRE; DCB:IMPACT (6MM*12CM); DCB:IMPACT (6MM*15CM); SHEATH (6F*28CM PARENT); TREASURE FLOPPY GUIDEWIRE
• Patient Age: 87 YR
• Patient Sex: Male