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

Catalog Number	140008055
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	08/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end user who completed the voluntary event report mw5097082 did not identify themselves.A ship history of the reported packaging lot 5683610 was shipped to multiple different end user facilities.Follow up for additional information could not be performed as end user is still unknown.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 review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.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.Warnings: do not use this catheter with alcohol.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).
Event or Problem Description
Angiodynamics received a medwatch report regarding a total abscession drainage cath 12fx30cm.The complainant reported the tip of the catheter broke off and was retained inside the patient when the catheter was being removed.Imaging had been performed, which showed the tip was kinked.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.No account/customer identifying information was provided.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: 12533391
• Report Number: 1319211-2021-00068
• Device Sequence Number: 1479623
• Product Code: FGE
• UDI-Device Identifier: H787140008055
• UDI-Public: H787140008055
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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: 06/30/2024
• Device Catalogue Number: 140008055
• Device Lot Number: 5683610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1