MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 39 X 70 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG3970BPS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, after deployment of a 39mm x 70mm 80cm palmaz genesis transhepatic biliary stent delivery system (sds) on.035 opta pro, the stent moved locations.Additional information was requested but was not provided.The device will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82221935 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.
Additional Manufacturer Narrative
Complaint conclusion: after deployment of a 39mm x 70mm 80cm palmaz genesis transhepatic biliary stent delivery system (sds) on.035 opta pro, the stent moved locations.Additional information was requested but was not provided.The product was not returned for analysis.A product history record (phr) review of lot 82221935 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.The exact cause could not be determined.Procedural images were not provided for review.Vessel characteristics (although unknown) may have contributed to the reported event.According to the safety information in the instructions for use ¿prior to stenting, the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system should be examined to verify functionality and integrity.Inspect the crimped stent for adherence to the balloon and centered placement in relation to the balloon marker bands.Do not reposition the stent or hand crimp.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.B.Under fluoroscopy, use the balloon marker bands and the radiopaque stent to position the stent centrally within the stricture.During positioning, verify that the stent is still centered within the balloon marker bands and has not been dislodged.¿ neither the phr review nor the very limited information provided 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: LONG GEN / PRO 39 X 70 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: 15352681
• Report Number: 9616099-2022-05940
• Device Sequence Number: 20346054
• Product Code: FGE
• UDI-Device Identifier: 20705032040034
• UDI-Public: (01)20705032040034(17)240430(10)82221935
• 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): 09/08/2022

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: 04/30/2024
• Device Model Number: PG3970BPS
• Device Catalogue Number: PG3970BPS
• Device Lot Number: 82221935
• 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: 09/07/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/08/2022
• Date Device Manufactured: 05/19/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown