MAUDE Adverse Event Report: ANGIODYNAMICS EXODUS DRAINAGE CATHETER; BILIARY (GENERAL) (NEPHOSTROMY) DRAINAGE CATHETER

Catalog Number	10525
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
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 investigation will be sent via a follow up medwatch.Reference (b)(4).(october 20, 2020); correction: this mdr was submitted under the incorrect number of 1317056-2020-00300 on october 19 2020.This report is being submitted as the correct numbering sequence of 1317056-2020-00157.Please void / disregard mdr 1317056-2020- 00300.Note: the supplemental to this report was submitted on december 11 2020.The acknowledgment receipt stated the submission failed as the initial report was not received.(angiodynamics has the receipts that it was received, it was submitted as an initial, and as a correction (incorrect numbering sequence (see above note) on october 20, 2020).Due to this notification, this "initial" report is being resubmitted.The supplemental report will also be resubmitted after the receipts and acknowledgments for the "initial" report are received.
Event or Problem Description
An angiodynamics territory manager reported that a patient's exodus 8f biliary drainage catheter was observed through imaging to have split into two pieces, right by the pigtail inside of the patient's liver.An additional procedure was performed to remove the catheter tip (requiring additional patient sedation).The device was not replaced as the device was being removed at end of treatment.It was reported the patient was post-op whipple.There was no permanent harm or injury to this patient due to this event.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was a used drainage catheter.As received, the catheter was fractured in two {2} places and the female hub was cracked.The drainage catheter was contained with biomaterial inside and out.Drainage catheters are a purchased device from supplier (b)(4).(b)(4).The device was forwarded to angiodynamics' supplier of this product for an evaluatin and root cause determination.(b)(4), confirmed that the shaft material disintegrated.There were no changes or issues found related to the assembly of the catheter or extrusion.The failure mode cannot be determined for the catheter fracture.The catheter sample returned from freudenberg for further analysis of the markerband.Freudenberg does not perform x-ray imaging as part of their incoming inspection.The complaint sample had x-ray imaging taken next to a biliary control sample.No issues were observed, the markerband is visible under x-ray and is comparable to the control sample.The customer's reported complaint description of catheter fractured was confirmed.The customer's reported complaint description of markerband is not visible under x-ray imaging is not confirmed.A root cause forthe catheeter fracture could not be determine.The patient is post whipple procedure with re-structuring of the gi tract.A result of this re-structuring is the location of the biliary tree into the small intestine is segregated from the normal flow of stomach contents.Potential contributing factor unique to this situation is drainage catheter tip in small intestine is not constantly "flushed" with contents of stomach such that stagnant small intestine environment adversely affects catheter material.A review of the device 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.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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: EXODUS DRAINAGE CATHETER
• Common Device Name: BILIARY (GENERAL) (NEPHOSTROMY) DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10991866
• Report Number: 1319211-2020-00157
• Device Sequence Number: 3548395
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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 Catalogue Number: 10525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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: Other
• Patient Age: 63 YR