MAUDE Adverse Event Report: CORDIS US. CORP PALMAZ GENESIS ON OPTA PRO; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	PG2980BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the stent of a 29 x 80 135cm palmaz genesis biliary on opta pro stent delivery system (sds) slid off the balloon before entering the patient.There was no reported injury to the patient.The device was stored and handled per the instructions for use (ifu) and there was no damage to the device packaging prior to use.There was no difficulty removing the device from its sterile packaging.The stent was not manipulated on the delivery system and the balloon was not inflated to maintain the stent placement on the delivery system.The device will be returned for evaluation.
Additional 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.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82233409 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.
Additional Manufacturer Narrative
Complaint conclusion: the stent of a 29 x 80 135cm palmaz genesis on opta pro biliary stent delivery system (sds) slid off the balloon before entering the patient.There was no reported injury to the patient.The device was stored and handled per the instructions for use (ifu) and there was no damage to the device packaging prior to use.There was no difficulty removing the device from its sterile packaging.The stent was not manipulated on the delivery system and the balloon was not inflated to maintain the stent placement on the delivery system.The product was returned for analysis.A non-sterile unit of long palmaz gen / pro 29 x 80mm bil 135cm sds was received coiled inside of a clear plastic bag.Per visual analysis the balloon was received not inflated, and it was observed that the stent was still mounted in the balloon nevertheless a proximal displacement was noted.No other damages or anomalies were observed on the returned unit.Per microscopic analysis stent struts marks were observed on the balloon surface.This indicates that the device complied with the stent crimp process.A product history record (phr) review of lot 82233409 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.The device was returned with a proximally displaced stent that according to the conditions observed it was previously properly mounted on the balloon, as the stent struts marks were observed on the balloon surface indicating that the device complied with the stent crimp process.Based on the information available for review, procedural or handling factors may have contributed to the event.According to the safety information in the instructions for use ¿the cordis palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system is indicated for palliation of malignant neoplasms in the biliary tree.The safety and effectiveness of the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system for use in the vascular system have not been established.Prior to stenting, the palmaz genesis transhepatic biliary 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.

• Brand Name: PALMAZ GENESIS ON OPTA PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17325621
• Report Number: 3007635982-2023-00237
• Device Sequence Number: 5509734
• Product Code: LIT
• UDI-Device Identifier: 20705032039724
• UDI-Public: (01)20705032039724(17)240831(10)82233409
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: PG2980BPX
• Device Lot Number: 82233409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 09/11/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/11/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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: UNK.
• Patient Sex: Unknown