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

Model Number	PG3980BPS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, once the palmaz genesis 39 x 80 stent was deployed; however, it moved locations an new stent was used which worked good.There was no reported injury to the patient.There were no anomalies noted prior to use.The device was stored according to the instructions for use (ifu).The device was removed from packaging in a sterile manner according to the indications, removed from its packaging and ¿flushed¿ before use.The stent was properly mounted on the system when inspected prior to use.There were no abnormalities noted prior to use.The sds was prepared in accordance with the ifu guidelines.There was no difficulty noted during prep.The stent was not manipulated prior to inserting into the patient, it was only flushed with a heparin solution prior to insertion.The lesion was in the right and left iliac and angioplasty was being performed.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion (cto).An unknown 6f sheath was used along with a non-cordis 150cm wire.A non-cordis 5f 65cm guide catheter was also used.The balloon on the system was not inflated before inserting into the patient.Negative pressure was not applied to the balloon.The inflator was in a neutral position when the system was advanced.There was no resistance while inserting the device through the rotating hemostatic valve.There was no resistance while inserting into the guide catheter.The catheter advanced to the lesion without difficulty and cross without difficulty.Unusual force was not used at any time during the procedure.The catheter was never in a sharp bend.The device was easily removed from the patient.The device will not be returned for evaluation.There are no images showing the migration and/or the lesion.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, h1, h2, h3 and h6 once the palmaz genesis 39 x 80 stent was deployed; however, it moved locations and a new stent was used which worked well.There was no reported injury to the patient.There were no anomalies noted prior to use.The device was stored according to the instructions for use (ifu).The device was removed from packaging in a sterile manner according to the indications, removed from its packaging and ¿flushed¿ before use.The stent was properly mounted on the system when inspected prior to use.There were no abnormalities noted prior to use.The sds was prepared in accordance with the ifu guidelines.There was no difficulty noted during prep.The stent was not manipulated prior to inserting into the patient, it was only flushed with a heparin solution prior to insertion.The lesion was in the right and left iliac and angioplasty was being performed.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion (cto).An unknown 6f sheath was used along with a non-cordis 150cm wire.A non-cordis 5f 65cm guide catheter was also used.The balloon on the system was not inflated before inserting into the patient.Negative pressure was not applied to the balloon.The inflator was in a neutral position when the system was advanced.There was no resistance while inserting the device through the rotating hemostatic valve.There was no resistance while inserting into the guide catheter.The catheter advanced to the lesion without difficulty and cross without difficulty.Unusual force was not used at any time during the procedure.The catheter was never in a sharp bend.The device was easily removed from the patient.The product was not returned for analysis.A device history record (dhr) review of lot 82214934 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent migration¿ could not be confirmed as the device was not returned for analysis, nor were procedural images provided for review.The exact cause could not be determined.Vessel characteristics of calcification 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.¿ this device is not intended for use in the vasculature; therefore, this is considered off label usage.Neither the dhr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.
Event or Problem Description
As reported, once the palmaz genesis 39 x 80 stent was deployed; however, it moved locations an new stent was used which worked good.There was no reported injury to the patient.There were no anomalies noted prior to use.The device was stored according to the instructions for use (ifu).The device was removed from packaging in a sterile manner according to the indications, removed from its packaging and ¿flushed¿ before use.The stent was properly mounted on the system when inspected prior to use.There were no abnormalities noted prior to use.The sds was prepared in accordance with the ifu guidelines.There was no difficulty noted during prep.The stent was not manipulated prior to inserting into the patient, it was only flushed with a heparin solution prior to insertion.The lesion was in the right and left iliac and angioplasty was being performed.The lesion was noted to be calcified.The vessel did not have any tortuosity.The device was not being used to treat a chronic total occlusion (cto).An unknown 6f sheath was used along with a non-cordis 150cm wire.A non-cordis 5f 65cm guide catheter was also used.The balloon on the system was not inflated before inserting into the patient.Negative pressure was not applied to the balloon.The inflator was in a neutral position when the system was advanced.There was no resistance while inserting the device through the rotating hemostatic valve.There was no resistance while inserting into the guide catheter.The catheter advanced to the lesion without difficulty and cross without difficulty.Unusual force was not used at any time during the procedure.The catheter was never in a sharp bend.The device was easily removed from the patient.The device will not be returned for evaluation.There are no images showing the migration and/or the lesion.

• Brand Name: LONG GEN / PRO 39 X 80 BIL 80
• 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: 15352678
• Report Number: 9616099-2022-05941
• Device Sequence Number: 6049721
• Product Code: FGE
• UDI-Device Identifier: 20705032040119
• UDI-Public: (01)20705032040119(17)240131(10)82214934
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: PG3980BPS
• Device Catalogue Number: PG3980BPS
• Device Lot Number: 82214934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/29/2022
• Date Device Manufactured: 10/22/2021
• 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: 150CM BENTSON; 5F BERENSTEIN CATH; UNK STENT
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Unknown