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

Catalog Number	H965105401
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device is not available for return to the manufacturer for evaluation.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An exodus multipurpose drainage catheter was placed in a patient.Post procedure, it was noted the hub of the catheter was cracked.The drain was removed and replaced.There was no harm or injury to the patient due to this event.The reported defective disposable device is not available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A ship history records review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The drainage catheter component is supplied to angiodynamics by the supplier, freudenberg medical.Freudenberg medical has been notified via scar004051 for dhr review of supplier lots identified through a ship history review.Freudenberg medical reviewed the dhr record for the noted lot and found no discrepancies related to this defect during manufacturing.Reference scar004051 response for complete details.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
• MDR Report Key: 9740977
• Report Number: 1317056-2020-00039
• Device Sequence Number: 1802287
• Product Code: FGE
• UDI-Device Identifier: H965105401
• UDI-Public: H965105401
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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 Catalogue Number: H965105401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1