MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 80 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2980BPS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.A review of the manufacturing documentation associated with this lot#: 82208517 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Before prep, the operator noticed the 29 x 80 x 80 palmaz genesis transhepatic biliary stent delivery system (sds) on.035" opta pro was not crimped on the balloon, but instead was on the balloon shaft.Additional stent (unknown) was opened to complete case.There was no reported patient injury.The product was opened on sterile table.The sent was not manipulated during prep, the stent was not properly mounted on the system when inspected prior to use.The issue was noticed upon opening the package and the device was not prepped.The operator was a trained user.The device will not be returned for analysis as it was discarded at the facility.
Additional Manufacturer Narrative
Before prep, the operator noticed the 29 x 80 x 80 palmaz genesis transhepatic biliary stent delivery system (sds) on.035" opta pro was not crimped on the balloon, but instead was on the balloon shaft.Additional stent (unknown) was opened to complete case.There was no reported patient injury.The product was opened on sterile table.The stent was not manipulated during prep, the stent was not properly mounted on the system when inspected prior to use.The issue was noticed upon opening the package and the device was not prepped.The operator was a trained user.The product was not returned for analysis.A product history record (phr) review of lot 82208517 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent loose crimp - 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.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.¿ neither the phr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: LONG GEN / PRO 29 X 80 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12042561
• Report Number: 9616099-2021-04662
• Device Sequence Number: 3820873
• Product Code: FGE
• UDI-Device Identifier: 20705032039717
• UDI-Public: 20705032039717
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 10/31/2023
• Device Model Number: PG2980BPS
• Device Catalogue Number: PG2980BPS
• Device Lot Number: 82208517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1