MAUDE Adverse Event Report: CORDIS DE MEXICO LONG GEN / PRO 19 X 10 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG1910BPS
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported by the customer via telephone, the palmaz genesis pro was inflated but the balloon could not expand nor the stent couldn't be deployed.There was difficulty withdrawing the system out of the patient and the stent dislodged from the balloon into the patient while withdrawing.Snaring was necessary to retrieve the stent, no patient injury was reported.
Additional Manufacturer Narrative
As reported by the customer via telephone, the palmaz genesis pro was inflated but the balloon could not expand nor could the stent be deployed.There was difficulty withdrawing the system out of the patient and the stent was dislodged from the balloon into the patient while withdrawing.Snaring was necessary to retrieve the stent but no patient injury was reported.The product was returned for analysis.A non-sterile palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system stent delivery system was returned.Per visual analysis the balloon did not appear to have been inflated.The stent and the involved guiding catheter were not returned.No other anomalies were noted.Per microscopic analysis stent struts marks were noted on the balloon.This indicates that the device complied with the stent crimp process.Per functional analysis it was not possible to inflate the balloon.Per dimensional analysis, the od proximal seal was found within specification.The device body was cross sectioned close to the proximal balloon seal and it was noted that the inflation lumen was obstructed.Therefore it was determined that the failure is related to the manufacturing process.A device history record (dhr) review of lot 17461866 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent - dislodged - in patient/while pulling back into gc/sheath¿ and ¿balloon - inflation difficulty - unable to inflate¿ were confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, procedural factors may have contributed to the dislodged stent as evidenced by the condition of the device as returned noted during analysis.The reported ¿pta/ptca system - withdrawal difficulty - unable to¿ was not confirmed through analysis of the returned device as the stent was not returned for functional analysis.The exact cause of the event could not be determined during analysis.According to 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.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.The reported event was added to a current capa investigating this issue.

• Brand Name: LONG GEN / PRO 19 X 10 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: 6378237
• Report Number: 9616099-2017-00940
• Device Sequence Number: 47332
• Product Code: FGE
• UDI-Device Identifier: 20705032038666
• UDI-Public: 20705032038666
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: PG1910BPS
• Device Catalogue Number: PG1910BPS
• Device Lot Number: 17461866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Distributor Facility Aware Date: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention