MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 90 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2990BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82185924 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.
Event or Problem Description
As reported, after backing out the 29 x 90 x 135 palmaz long genesis transhepatic biliary stent, the users noticed the stent laying on the drape undeployed.Therefore, the users deployed a non-cordis stent.There was no reported patient injury.Initially, the users went to load the device on an unknown wire and deployed it, however, after deployment, the users were not able to see the stent under flouroscopy (fluro).After the users deployed a non-cordis stent, they checked the palmaz device since they never had this happened.The doctor put the stent onto the unknown balloon and partially deployed it, curious to know if it was the stent or not.The device will be returned for analysis.
Additional Manufacturer Narrative
After backing out the 29 x 90 x 135 palmaz long genesis transhepatic biliary stent, the users noticed the stent laying on the drape undeployed.Therefore, the users deployed a non-cordis stent.There was no reported patient injury.Initially, the users went to load the device on an unknown wire and deployed it, however, after deployment, the users were not able to see the stent under fluoroscopy.After the users deployed a non-cordis stent, they checked the palmaz device since they never had this happen.The doctor put the stent onto the unknown balloon and partially deployed it, curious to know if it was the stent or not.The product was returned for analysis.One non-sterile long genesis / pro 29 x 90 biliary 135cm stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the balloon looks like it¿s been previously inflated since the balloon is observed expanded and water residues inside of it.Also, the stent was not returned inside the plastic bag.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 82185924 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 not 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, handling or procedural factors may have contributed to the event as evidenced by fluid noted in the balloon and signs of balloon expansion during analysis.This indicates the balloon may have been improperly prepped prior to delivery to the lesion or stricture.This would cause the stent to loosen on the balloon if positive pressure was exerted on the balloon prior to delivery to the lesion or stricture with a likely result that the stent may fall off.Stent marks on the balloon indicates the stent was appropriately crimped onto the balloon during manufacture.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 90 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10334141
• Report Number: 9616099-2020-03810
• Device Sequence Number: 825908
• Product Code: FGE
• UDI-Device Identifier: 20705032039809
• UDI-Public: 20705032039809
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 01/31/2023
• Device Model Number: PG2990BPX
• Device Catalogue Number: PG2990BPX
• Device Lot Number: 82185924
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK BALLOON CATHETER; UNK STENT; UNK WIRE; UNK BALLOON CATHETER; UNK STENT; UNK WIRE