MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 90 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2990BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82208532 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
When the physician prepped a palmaz genesis stent on.035¿ 29 x 90 opta pro balloon expandable-stent delivery system, the stent fell off the balloon catheter before it was placed in the body.There was no reported patient injury.The product was stored as per labeling.The product was inspected per the ifu.The device was prepped according to the instructions for use (ifu) and opened in a sterile field.The device prepped normally.The device was not used in patient.There was no difficulty removing the product from the hoop.There was no difficulty removing the stylet or any of the sterile packaging components.No anomalies were noted after removal from the package.The intended procedure/lesion was the iliac artery.There was no calcification in the iliac artery, however the lesion did have a 90% stenosis.The device was not being used for a chronic total occlusion (cto).The case was completed successfully after the use of another palmaz device.The device will not be returned for evaluation as it was thrown away.
Additional Manufacturer Narrative
When the physician prepped a palmaz genesis stent on.035¿ 29 x 90 opta pro balloon expandable-stent delivery system, the stent fell off the balloon catheter before it was placed in the body.There was no reported patient injury.The product was stored as per labeling.The product was inspected per the instructions for use (ifu).The device was prepped according to the ifu and opened in a sterile field.The device prepped normally.The device was not used in patient.There was no difficulty removing the product from the hoop.There was no difficulty removing the stylet or any of the sterile packaging components.No anomalies were noted after removal from the package.The intended procedure/lesion was the iliac artery.There was no calcification in the iliac artery, however the lesion did have a 90% stenosis.The device was not being used for a chronic total occlusion (cto).The case was completed successfully after the use of another palmaz device.The product was not returned for analysis.A product history record (phr) review of lot 82208532 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.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.¿ as this product is not intended for vascular implantation this is considered an intended off label usage.Neither the phr nor the 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 90 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12076076
• Report Number: 9616099-2021-04669
• Device Sequence Number: 4765288
• Product Code: FGE
• UDI-Device Identifier: 20705032039793
• UDI-Public: 20705032039793
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/01/2021

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: PG2990BPS
• Device Catalogue Number: PG2990BPS
• Device Lot Number: 82208532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 82