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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 30mm x 80cm x 80cm palmaz genesis transhepatic biliary stent delivery system (sds) was not mounted on the balloon when the physician opened the package.There was no reported patient injury since it was not clinically used in the patient.The device will not be returned for analysis.
Additional Manufacturer Narrative
A 30mm x 80cm x 80cm palmaz genesis transhepatic biliary stent delivery system (sds) was not mounted on the balloon when the physician opened the package.The procedure was completed successfully with the use of another stent.There was no reported patient injury since it was not clinically used in the patient.The device was stored and prepped as per the instructions for use (ifu).There was no damage noted to the packaging of the device.No stent was found in the packaging.The event resulted in a procedural delay.Additional procedural details were requested but are unknown.The device was not returned for analysis.A product history record (phr) review of lot 17780141 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint stent- dislodged - during prep could not be confirmed and no determination of possible contributing factors could be made.According to the safety information in the instructions for use ¿prior to stenting, the palmaz genesis transhepatic biliary stent system should be examined to verify functionality and integrity.Do not attempt to remove or readjust the stent on the delivery system.¿ 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.
Additional Manufacturer Narrative
Additional information was received that the device was stored and prepped as per the instructions for use (ifu).There was no damage noted to the packaging of the device.No stent was found in the packaging.The procedure was completed successfully with the use of another palmaz genesis stent.The event resulted in a procedural delay.Additional procedural details were requested but are unknown.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was returned and section d10 was updated accordingly.The completed engineering report will be submitted within (b)(4) days upon receipt.
Additional Manufacturer Narrative
The final report was updated with analysis of the returned device: a 30mm x 80cm x 80cm palmaz genesis transhepatic biliary stent delivery system (sds) was not mounted on the balloon when the physician opened the package.The procedure was completed successfully with the use of another stent.There was no reported patient injury since it was not clinically used in the patient.The device was stored and prepped as per the instructions for use (ifu).There was no damage noted to the packaging of the device.No stent was found in the packaging.The event resulted in a procedural delay.Additional procedural details were requested but are unknown.The product was returned for analysis.One non-sterile long genesis / 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 appears to have been previously inflated.The stent was not returned.No other anomalies were observed.Per microscopic analysis, stent marks were observed on the outer surface of the balloon catheter.A product history record (phr) review of lot 17780141 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.Based on the information available for review, procedural or handling factors (although unknown) may have contributed to the event as evidenced by stent crimp marks noted on the outer surface of the balloon during analysis suggest the stent was correctly crimped onto the balloon, and there is evidence the balloon has been inflated.According to the safety information in the instructions for use ¿prior to stenting, the palmaz genesis transhepatic biliary stent system should be examined to verify functionality and integrity.Do not attempt to remove or readjust the stent on the delivery system.¿ 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 DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 9481039
• Report Number: 9616099-2019-03405
• Device Sequence Number: 3541956
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/04/2020

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: PG2980BPS
• Device Lot Number: 17780141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 12/30/2019; 02/06/2020; 02/26/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 12/26/2019; 12/31/2019; 02/11/2020; 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1