MAUDE Adverse Event Report: CORDIS US. CORP PALMAZ GENESIS ON OPTA PRO; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number PG3980PPS

Device Problem Leak/Splash (1354)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

As reported, when the physician flushed the.035 8.0x39 genesis stent catheter through the guidewire port, there was a leak on the proximal portion of the catheter.The luer hub for flushing had the leak.On the other hand, there was no leak on the inflation port.The balloon could be inflated, and the stent was placed.There was no reported injury to the patient.The was noticed prior to inserting into the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped per the ifu.Besides the leak, there was no difficulties noted during prep.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The intended procedure was a percutaneous transluminal angioplasty (pta).The lesion was 8mm in diameter.The lesion was noted to have calcification and the vessel did not have tortuosity.The device was not being used to treat a chronic total occlusion (cto).The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

When the physician flushed the.035 8.0x39mm genesis stent delivery system (sds) through the guidewire port, there was a leak on the proximal portion of the catheter.The luer hub for flushing had the leak.On the other hand, there was no leak on the inflation port.The balloon could be inflated, and the stent was placed.The intended procedure was a percutaneous transluminal angioplasty (pta).The lesion was 8mm in diameter.The lesion was noted to have calcification and the vessel did not have tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no reported injury to the patient.The was noticed prior to inserting into the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped per the ifu.Besides the leak, there was no difficulties noted during prep.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The product was returned for analysis.A non-sterile genesis.035 8.0x39mm 80cm sds was received coiled inside of a clear plastic bag.The balloon was received without being inflated.The unit was thoroughly inspected, and no damages or anomalies were observed neither on the balloon nor on the rest of the device.Per functional analysis the device was flushed after attaching a syringe full of water to the guidewire port and applying positive pressure.The water flowed through the guide wire lumen and went out at the opposite side.No obstruction, or any leakage condition, was observed.One inflator/deflator device was attached to the inflation port.Balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reach the rated burst pressure.The balloon inflated as expected with a steady pressure.No leakage condition was observed.Per microscopic analysis the hub was inspected.No damages or anomalies were observed.A product history record (phr) review of lot 82241190 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub leakage¿ was not confirmed through analysis of the returned device.No leakage was noted during functional analysis.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the reported event.According to the precautions in the safety information in the instructions for use ¿prior to stenting, the palmaz genesis peripheral stent on opta pro.035" delivery system should be examined to verify functionality and integrity.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, when the physician flushed the.035 8.0x39 genesis stent catheter through the guidewire port, there was a leak on the proximal portion of the catheter.The luer hub for flushing had the leak.On the other hand, there was no leak on the inflation port.The balloon could be inflated, and the stent was placed.There was no reported injury to the patient.The was noticed prior to inserting into the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped per the ifu.Besides the leak, there was no difficulties noted during prep.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The intended procedure was a percutaneous transluminal angioplasty (pta).The lesion was 8mm in diameter.The lesion was noted to have calcification and the vessel did not have tortuosity.The device was not being used to treat a chronic total occlusion (cto).The device will be returned for evaluation.

• Brand Name: PALMAZ GENESIS ON OPTA PRO
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 32574
• Manufacturer (Section G): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16529997
• MDR Text Key: 311311679
• Report Number: 9616099-2023-06325
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032040157
• UDI-Public: (01)20705032040157(17)250228(10)82241190
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033394
• 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: 05/01/2023

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
• Device Operator: Health Professional
• Device Model Number: PG3980PPS
• Device Catalogue Number: PG3980PPS
• Device Lot Number: 82241190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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: UNK GUIDE CATHETER; UNKNOWN GUIDE CATHETER
• Patient Sex: Male