MAUDE Adverse Event Report: COOK IRELAND LTD JOHLIN PANCREATIC WEDGE STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G26831
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
This file was created to capture off label use.An ercp was being performed where two previously placed zilver stents are in place in the left and right hilum.The user cannulated both sides with 2 different wires and balloon sweeps were performed.An extraction balloon was used to remove some tumor ingrowth.The 6mm titan balloon was used to dilated both sides.Two johlin pancreatic wedge stents were placed.While the user was deploying one of the stents, pulling back on the guiding catheter, the white knob on the end of the guiding catheter ripped off.The user was able to deploy the stent by holding onto the black portion of the catheter.The stent was placed successfully.Clinical input received the 29-jun-2020 confirming that two pancreatic stents being placed in bile duct was off-label use.
Event or Problem Description
Cancellation report being submitted as (b)(4) (emdr 3001845648-2020-00458) was created to capture off-label of two pancreatic stents being placed in bile duct as outlined in (b)(4) (3001845648-2020-00130).However this off label use will now be captured under the final report of original file of(b)(4) (3001845648-2020-00130).Current pr no longer required.
Additional Manufacturer Narrative
Cancellation report being submitted as (b)(4) (emdr 3001845648-2020-00458) was created to capture off-label of two pancreatic stents being placed in bile duct as outlined in (b)(4) (3001845648-2020-00130).However this off label use will now be captured under the final report of original file of (b)(4) (3001845648-2020-00130).Current pr no longer required.

• Brand Name: JOHLIN PANCREATIC WEDGE STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10327230
• Report Number: 3001845648-2020-00458
• Device Sequence Number: 11394464
• Product Code: FGE
• UDI-Device Identifier: 10827002268316
• UDI-Public: (01)10827002268316(17)210928(10)C1544283
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K990130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/21/2021

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: 09/28/2021
• Device Model Number: G26831
• Device Catalogue Number: JPWS-8.5-20
• Device Lot Number: C1544283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1