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

Catalog Number	H965105251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device is not available be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
Physician stated that the patient came in for the exchange/upsize of an 8f exodus biliary drainage catheter.During the procedure, during the advancement of the wire, the tip broke off, at the mid-pigtail.Snares were used to try to extract the tip during the procedure, however it was unsuccessful and the tip was then left in the small intestine for the patient to pass on his own.A 10f cook biliary drain was then put in place and the procedure concluded.There was no permanent harm or injury to the patient due to this event.It was reported the defective disposable device is not available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics was unable to perform a device evaluation.As a device evaluation was not performed, the reported complaint description cannot be confirmed.A root cause for the event cannot be determined.The reported complaint description cannot be confirmed as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A ship history report (shr) was generated for item number (h965105251) in order to ascertain the last three lots shipped in the six months prior to the procedure date.The three lots obtained through the shr were: (0000061879, 0000070076 and 0000074836).Drainage catheters are a purchased device.Angiodynamics' supplier of this device was notified of the event and provided with the potential lot numbers for a device history review (dhr) for each potential lot number.The supplier's review of the dhr for the noted lots was performed and there were no observations noted that indicate the reported conditions were a result of a manufacturing defect.In addition, a review of the catheter extrusion lots and the base material resin lots associated with the devices in question were reviewed.There was no common denominator observed that would indicate the tip fracture events were related to material or catheter extrusion issues.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." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: EXODUS DRAINAGE CATHETER
• Common Device Name: BILIARY DRAINAGE CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8893030
• Report Number: 1317056-2019-00101
• Device Sequence Number: 13532559
• Product Code: FGE
• UDI-Device Identifier: H965105251
• UDI-Public: H965105251
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H965105251
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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