MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM10CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002030X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82234619 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 or Problem Description
As reported, after the insertion of a 5mm x 10cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter, an attempt to inflate the balloon was made but the inflation failed.It was reported that the inflation difficulty may have been caused by a leakage of pressure from the shaft of the device.As a result, the device was removed, and a 5mm saberx pta balloon catheter was used and was successfully inflated.The procedure was completed with the use of an unknown drug-coated balloon (dcb) catheter.There was no reported injury to the patient.This was during a procedure to treat restenosis of a previously placed unknown stent within the superficial femoral artery (sfa).An ipsilateral approach was used for this procedure.An unknown.014 guidewire was also used and was advanced across the lesion.Additional information was requested but was not available.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, after the insertion of a 5mm x 10cm 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter, an attempt to inflate the balloon was made but the inflation failed.It was reported that the inflation difficulty may have been caused by a leakage of pressure from the shaft of the device.As a result, the device was removed, and a 5mm saberx pta balloon catheter was used and was successfully inflated.The procedure was completed with the use of an unknown drug-coated balloon (dcb) catheter.There was no reported injury to the patient.This was during a procedure to treat restenosis of a previously placed unknown stent within the superficial femoral artery (sfa).An ipsilateral approach was used for this procedure.An unknown.014 guidewire was also used and was advanced across the lesion.Additional information was requested but was not available.The device was returned for analysis.A non-sterile saber 5mm10cm 90 was received for analysis coiled inside a plastic bag.Per visual analysis, a cracked condition in the inflation luer hub of the unit was observed.Per functional testing, a lab sample inflator/deflator device filled with water was attached to the inflation lumen of the unit and pressure was applied.However, a leakage was observed at a rupture in the inflation luer hub.No other anomalies were observed.Per microscopic analysis, the unit was sent to sem analysis to determine the root cause of the cracked hub.Sem results showed a cracked condition was observed on the luer hub surface extending along the entire length of the luer hub body in the balloon tube section.The results showed that the areas affected by the crack on the luer hub of the saber 5mm10cm90 catheter unit presented evidence of an overloading force that occurred on the damaged area of the unit.The crack damages on these materials are commonly associated with damages caused in polymeric materials where shear forces resistance propertied were overloaded.These polymers exhibit considerable mechanical properties, nevertheless under severe conditions tend to break after the elastic behavior is exceed, as in this case may be observed in the fatigue striation patterns observed in the separated wall borders.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 82234619 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft leakage - in-patient¿ was confirmed during device analysis as a leakage was noted coming from the luer hub on the device.Device analysis revealed a cracked condition extending the entire length of the luer hub.Based on the information provided, the hub material was likely induced to tensile forces that exceeded the hub material yield strength.It is likely handling of the product and procedural factors contributed to the event reported.Overtightening is the likely culprit and has been known to cause cracks in luer hubs as fatigue striation patterns were observed in the separated wall borders.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 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: SABER 5MM10CM 90
• Common Device Name: 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: 15581863
• Report Number: 9616099-2022-06052
• Device Sequence Number: 17759970
• Product Code: LIT
• UDI-Device Identifier: 20705032069233
• UDI-Public: (01)20705032069233(17)240430(10)82234619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 48002030X
• Device Catalogue Number: 48005010S
• Device Lot Number: 82234619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER SABERX (5); UNK GUIDEWIRE (0.014); UNK STENT
• Patient Sex: Unknown