MAUDE Adverse Event Report: ANGIODYNAMICS TOTAL ABSCESSION GENERAL DRAINAGE CATHETER

Catalog Number	H787140008065
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	04/24/2019
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.The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
Drainage catheter #2- the patient had a14f drainage catheter with locking pigtail successfully placed for necrotic collection in patient with pancreatitis.Approximately one week after placement, it was noted the catheter was not draining as intended.Ct images confirmed the pigtail inside the pocket and the shaft had detached/broken.(this device will be reported on medwatch 1319211-2019-00040) it was determined to remove the catheter and replace with 2 new drainage catheters.After some weeks, one of the newly placed catheters didn't produce and the same issue occurred, the pigtail in the pocket and no connection with the shaft.The fractured pieces were not retrieved, and the patient was scheduled for a procedure to remove the fragments at a later date.It was indicated that the pigtail tips are available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 14fx30cm drainage catheter.The drainage catheter was returned in 3 pieces.There was no evidence of material stretching at the site of the break, nor were there any obvious visual indications of damage during manufacture that could have led to compromised integrity.The catheter tubing was observed to be within dimension specification.This failure mode is consistent with excessive force being applied to the suture, most likely the result of difficulty in extraction of the device.The customer's reported complaint description of "the drainage catheter tip broke off" is confirmed.The catheter tubing was observed to be within dimension specification and there was no evidence of material stretching at the site of the break, nor were there any obvious visual indications of damage during manufacture that could have led to compromised integrity.A definitive root cause could not be determined, failure mode is consistent with material breakdown due to exposure to an incompatible substance, possibly alcohol.Labeling review: a review of the lot history records was performed for any deviations related to the reported defect of the complaint.The review confirmed that the packaging lots and all component lots met all material, assembly, and performance specification.The instructions for use, which is supplied to the end user with this catalog number, states: ""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 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: GENERAL DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8575003
• Report Number: 1319211-2019-00041
• Device Sequence Number: 2130819
• Product Code: FGE
• UDI-Device Identifier: H787140008065
• UDI-Public: H787140008065
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K002101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: 07/30/2020
• Device Catalogue Number: H787140008065
• Device Lot Number: 5214591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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