MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / EXODUS; BILIARY DRAINAGE CATHETER

Catalog Number	H965105251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although no device will be returned for evaluation, angiodynamics will be sending a supplier corrective action request (scar) to (b)(4), the manufacturer of the drainage catheter to notifiy them of the event and to request a review of the device history records.A supplemental medwatch will be submitted upon completion of the investigation.((b)(4)).
Event or Problem Description
As reported on user medwatch # (b)(4): "patient was undergoing routine biliary catheter exchange.When the existing drain (initially placed approximately 3 months ago) was wired during the procedure, the pigtail portion of the catheter broke off in the small bowel.External portion of catheter was removed and new catheter placed.No apparent harm to patient." it has been indicated that the used catheter will not be returned to angiodynamics.
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot (0000061879) for item number h965105251 for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The june 2019 angiodynamics complaint report was reviewed for the drainage catheter product family and the failure mode "tip fractured/migrated." no adverse trend was indicated.A supplier corrective action request (scar) was send by angiodynamics to freudenberg medical for informational purpose only.The hospital's reported complaint description cannot be confirmed, nor can a root cause be determined, as no sample was returned.Labeling review: the instructions for use which is supplied to the end user with this catalog number states, "warnings: do not use this catheter with alcohol.Placing a 10 french or larger catheter as the primary drain before formation of a tract may be difficult in some patients.In these patients, the initial biliary drainage should be started with a smaller (8 french) catheter until a suitable tract allows placement of a larger catheter.Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.This catheter should be evaluated by the physician on or before 90 days post placement." ((b)(4)).

• Brand Name: ANGIODYNAMICS / EXODUS
• Common Device Name: BILIARY DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8794412
• Report Number: 1317056-2019-00088
• Device Sequence Number: 2044020
• Product Code: FGE
• UDI-Device Identifier: H965105251
• UDI-Public: H965105251
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H965105251
• Device Lot Number: 0000061879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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
• Patient Age: 55 YR
• Patient Weight: 55