MAUDE Adverse Event Report: ANGIODYNAMICS TOTAL ABSCESSION GENERAL DRAINAGE CATHETER

Catalog Number	H787140008045
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fever (1858); Sepsis (2067); Urinary Tract Infection (2120); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on september 09, 2017: a patient had a drainage catheter placed during a scheduled nephrostomy.The patient was then sent home.Post procedure, the patient had returned to the emergency room with complaints of no urine output.It was reported that the patient's urine had not drained for 1-2 days, resulting in septic patient.Once the catheter was removed from patient, a guide wire was inserted in the tube and a small plastic piece of the catheter cap came out.A ct scan showed hydronephrosis.The patient was admitted to the hospital for fever, uti, and septic shock.It was reported the patient suffered no permanent harm due to this event.It was reported the defective disposable device is not available for return to the manufacturer for evaluation until after the customer's internal investigation is completed.
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 of a small piece of cap breaking off cannot be confirmed as a sample was not returned for evaluation.Without receiving product to evaluate, a definitive root cause cannot be determined.The complaint description states, "what cap broke? clear piece inside of the cap that the string attaches to (clear- dome shaped)".This is most likely referring to the dome shaped glue fillet that adheres the suture wire to the pull cap.Described in the design requirement document for general drainage catheters, the suture to pull cap bond must meet a minimum tensile strength equal to or greater than 2 lbs.Although it cannot be definitively determined, a possible contributing factor could be due to excessive force being placed on the suture to cap bond.If the bond breaks, it is possible for glue fillet to move into the catheter tubing, causing an occlusion.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.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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: TOTAL ABSCESSION GENERAL DRAINAGE CATHETER
• Common Device Name: TOTAL ABSCESSION GENERAL DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6907228
• Report Number: 1319211-2017-00100
• Device Sequence Number: 18859110
• Product Code: FGE
• UDI-Device Identifier: H787140008045
• UDI-Public: H787140008045
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K002101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: H787140008045
• Device Lot Number: 4951855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/07/2017
• 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: Hospitalization; Required Intervention