MAUDE Adverse Event Report: ANGIODYNAMICS TOTAL ABSCESSION DRAINAGE CATHETER; TOTAL ABSCESSION DRAINAGE CATHETER,

Catalog Number	14000803
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to 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.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a 8fx30 cm total abscession drainage catheter.The following was reported: "on (b)(6) 2020, a patient get an 8 f wire-locked abscess drain is inserted into a lymphocele on the left side next to the iliac vessels (lymphocele after lymph node evacuation).The drain should be used by the urologist to empty the lymphocyte and sclerosis it with alcohol." "on (b)(6) 2020, treatment is finished and the drain was going to be removed.The drain was cut near "the locking house" and in that way free the lock thread.A wire is inserted and the drain is pulled out, however the tip of the drain comes loose and remains, with the locking wire remaining through the tip.The doctor who pulled out the drain did not think that he had to pull hard on the drain at all.The drain tip is left together with the locking wires and a thin 4 f catheter to maintain the puncture path prior to extraction." "on (b)(6) 2020, the tip can be removed with a snare via an 11 f introducer.It was a piece about 3 cm long." it was reported the retained tip was successfully removed with no adverse patient impact.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was the reported catheter tip.The catheter tip shows cuts/breakage at the drainage holes.A review of the complaint sample indicated the catheter was broken approximately 3.5cm from the distal end and the suture wire had been pulled through the catheter sidewall.Only this portion of the catheter was returned.There was no evidence of material stretching, but the material exhibited signs of material degradation and was easily torn further.The customer's reported complaint description of "the drainage catheter tip of the drain came loose" is confirmed.As noted in the customers noted events: the drain should be used by the urologist to empty the lymphocyte and sclerosis it with alcohol." as noted in the provided dfu (uc 188) "warnings: do not use this catheter with alcohol." the probable root cause for the catheter tip becoming detached was due to the end user not following the provided instructions for use and flushed catheter with alcohol.The root cause was determined to be unintended user/use error.The failure mode is consistent with incompatible chemical exposure such as alcohol.Under the "warnings" section of the instructions for use, it is stated do not use this catheter with alcohol.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: TOTAL ABSCESSION DRAINAGE CATHETER
• Common Device Name: TOTAL ABSCESSION DRAINAGE CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10790560
• Report Number: 1319211-2020-00075
• Device Sequence Number: 3931663
• Product Code: FGE
• UDI-Device Identifier: H787140008035
• UDI-Public: H787140008035
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K170743
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 14000803
• Device Lot Number: 5563977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: Required Intervention