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	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An exodus multipurpose drainage catheter was placed in a patient.2 days later, 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 has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a drainage catheter and two unused samples.As received, the catheter tubing measured approximately 5cm long and the female hub was cracked.The drainage catheter contained biomaterial inside and out.Angiodynamics' supplier of this product was notified of the event and the sample was forwarded for a device evaluation and root cause determination.The customer's reported complaint description is confirmed.Per the investigation results from the supplier: one 8f sample was returned for evaluation.The full catheter was not returned.The catheter had been cut in half with only the proximal portion of the luer/hub assembly being returned.The sample was received with the knob in the locked position.The knob was unlocked and locked again.During the locking the audible "click" was heard on the sample.Visual examination confirmed that the hub body was cracked opposite of the parting line.All dimensional analysis conducted on the returned part from (b)(4) with no issues found.A failure mode cannot be determined.A review of the angiodynamics' device packaging history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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: 9740975
• Report Number: 1317056-2020-00026
• Device Sequence Number: 1802286
• 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 Implanted Year: 2020
• 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 Expiration Date: 05/31/2022
• Device Catalogue Number: H965105401
• Device Lot Number: 0000123921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• 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