MAUDE Adverse Event Report: ANGIODYNAMICS, INC TOTAL ABSCESSION GENERAL DRAINAGE CATHETER

Catalog Number	H787140008045
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident 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 august 01 2018: performed ct guided placement of an 8f pigtail drainage catheter in a peripancreatic collection on the evening of (b)(6) 2018 and ct guided placement of a 10f pigtail drainage catheter in a left upper quadrant fluid collection on (b)(6) 2018.The patient continued to do well while in the hospital, and was discharged home on (b)(6) 2018.Prior to his discharge the peripancreatic drain was removed, with anticipation of left upper quadrant pigtail drainage catheter removal as outpatient.Of note, a ct scan obtained on (b)(6) 2018, demonstrated both catheters to be intact.The left upper quadrant drainage catheter was functioning well prior to his discharge, with adequate output.The patient presented to the (b)(6)er on (b)(6) 2018 for shortness of breath.A ct scan of the chest was obtained while the patient was in the er , which demonstrated that the left upper quadrant abdominal drainage catheter was severed, with a retained pigtail catheter tip in the left upper quadrant of the abdomen (retained foreign body).It was reported the fragment was successfully removed.It was reported the defective disposable device is not available for return to the manufacturer.
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 as no sample was returned for evaluation.Without receiving the product to evaluate, a definitive root cause cannot be determined.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, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7822155
• Report Number: 1319211-2018-00087
• Device Sequence Number: 1573501
• Product Code: FGE
• UDI-Device Identifier: H787140008045
• UDI-Public: H787140008045
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K002101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 04/30/2021
• Device Catalogue Number: H787140008045
• Device Lot Number: 5321712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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
• Patient Age: 81 YR