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

Catalog Number	14000828
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	09/11/2020
Type of Reportable Event	Serious Injury
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 because no sample was returned for evaluation.Without receiving product to evaluate, a definitive root cause cannot be determined.In addition, it was not reported when the catheter broke inside of the patient, i.E.During the procedure or at some later date during use.A lot history records search for the drainage catheter revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The end user who completed the voluntary event report mw5097082 did not identify themselves.Ship history of the reported packaging lot 5553379 was shipped to 14 different end user facilities.Follow up could not be performed as end user is still unknown.Labeling review: the instructions for use, which is supplied to the end user with this catalog number states, "to tighten the pigtail shape, gently pull the suture until resistance is felt".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).
Event or Problem Description
Angiodynamics received a user medwatch reference mw5097082.No identifying customer/end user information was provided.A lot history records search for the drainage catheter revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The end user who completed the voluntary event report mw5097082 did not identify themselves.Ship history of the reported packaging lot 5553379 was shipped to 14 different end user facilities.Follow up could not be performed as end user is still unknown.An end user reported an issue with a total abscession 10fx30cm pigtail drainage catheter.The catheter spontaneously broke inside of the patient.The pigtail catheter was removed.No further information was provided.No identifying account information was provided.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

• 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: 10809595
• Report Number: 1319211-2020-00079
• Device Sequence Number: 4011848
• Product Code: FGE
• UDI-Device Identifier: H787140008285
• UDI-Public: H787140008285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 12/31/2022
• Device Catalogue Number: 14000828
• Device Lot Number: 5553379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/09/2020
• 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