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

Model Number	PG2980BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot 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
As reported, the physician wanted to use an 8mm x 30mm x 29mm 80cm palmaz genesis transhepatic biliary stent however, when the nurse opened the packaging, the stent was detached from the balloon.Therefore, the procedure was completed with another palmaz genesis stent.There was no reported patient injury.The device was stored and handled as per the instruction for use (ifu).There were no damages noted to the packaging of the device prior to use.There were no difficulty removing the device from its packaging.The nurse took the shaft from the hub to pull out from its packaging.The device was not used since the stent was not mounted on the balloon.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: the physician wanted to use an 8mm x 30mm x 29mm 80cm palmaz genesis transhepatic biliary stent delivery system (sds) however, when the nurse opened the packaging, the stent was detached from the balloon.Therefore, the procedure was completed with another palmaz genesis stent.There was no reported patient injury.The device was stored and handled as per the instruction for use (ifu).There were no damages noted to the packaging of the device prior to use.There were no difficulty removing the device from its packaging.The nurse took the shaft from the hub to pull out from its packaging.The device was not used since the stent was not mounted on the balloon.The product was returned for analysis.One non-sterile long gen / pro 29mm x 80mm biliary 80cm sds was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the balloon looks like it has been previously inflated.Also, the stent was observed not placed onto the balloon catheter; stent was observed partially deployed.No other anomalies were observed.Per microscopic analysis, stent crimp marks were observed on the outer surface of the balloon catheter indicating the stent was appropriately crimped onto the balloon.A product history record (phr) review of lot 82177198 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¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Nevertheless, stent marks were observed on the outer surface of the balloon catheter and balloon seemed that it was inflated previously.Also, stent was observed partially deployed.Based on the information available for review, procedural and/or handling factors may have contributed to the event as evidenced by the partially deployed stent and crimp marks on the balloon noted during analysis.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.Neither the phr review nor the product analysis 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 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: 9862945
• Report Number: 9616099-2020-03584
• Device Sequence Number: 19499099
• Product Code: FGE
• UDI-Device Identifier: 20705032039717
• UDI-Public: 20705032039717
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (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): 05/15/2020

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: 08/31/2022
• Device Model Number: PG2980BPS
• Device Catalogue Number: PG2980BPS
• Device Lot Number: 82177198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1