MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 39 X 80 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG3980BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: the stent of a 39mm x 8mm 135cm palmaz genesis biliary stent delivery system (sds) came off the balloon when removed from its packaging.As a result, the stent was not used, and a 7mm x 39mm palmaz genesis biliary stent delivery system (sds) on opta pro was used without issue to continue the procedure.There was no reported injury to the patient.There was no observed damage to the sterile packaging of the device, and no preparation of the device had been performed prior to the stent falling off the delivery system.The product was not returned for analysis.A product history record (phr) review of lot 82226836 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.Handling or shipping/storage factors may have contributed to the reported event.According to 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.Recrossing a partially or fully deployed stent with adjunct devices must be performed with extreme caution.Do not attempt to remove or readjust the stent on the delivery system.Neither the phr review nor the information provided suggests that the event experienced by the customer could be related to the manufacturing process; however, a risk assessment has been opened to further investigate this issue.
Event or Problem Description
As reported, the stent of a 39mm x 8mm 135cm palmaz genesis biliary stent delivery system (sds) came off the balloon when removed from its packaging.As a result, the stent was not used, and a 7mm x 39mm palmaz genesis biliary stent delivery system (sds) on opta pro was used without issue to continue the procedure.There was no reported injury to the patient.There was no observed damage to the sterile packaging of the device, and no preparation of the device had been performed prior to the stent falling off the delivery system.The device will not be returned for evaluation.

• Brand Name: LONG GEN / PRO 39 X 80 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 15079764
• Report Number: 9616099-2022-05839
• Device Sequence Number: 4814144
• Product Code: FGE
• UDI-Device Identifier: 20705032040126
• UDI-Public: (01)20705032040126(17)240531(10)82226836
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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: 05/31/2024
• Device Model Number: PG3980BPX
• Device Catalogue Number: PG3980BPX
• Device Lot Number: 82226836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/21/2022
• Date Device Manufactured: 06/24/2021
• 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: 7MM X 39MM PALMAZ GENESIS BILIARY SDS
• Patient Sex: Unknown