MAUDE Adverse Event Report: COOK INC UPJ OCCLUSION BALLOON CATHETER; EZL CATHETER, RETENTION TYPE, BALLOON

Catalog Number	028006
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that hydronephrosis was intentionally induced with the balloon to make percutaneous renal puncture easier for percutaneous nephrolithotripsy (pnl) procedure.The upj occlusion balloon catheter was advanced over a wire guide and when the balloon reached the ureteropelvic junction (upj), the physician attempted to inflate the balloon after connecting a syringe contained in the device set to the device connector.However, the balloon did not inflate and fluid leaked from the opposite end.It was further noted that a dried white substance was found around the obturator and the balloon catheter.In addition, the obturator/wire guide was noted to be broken and stretched out.There were no adverse effects reported due to the event and no report of an additional procedure.A new product was used.

• Brand Name: UPJ OCCLUSION BALLOON CATHETER
• Common Device Name: EZL CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8108596
• Report Number: 1820334-2018-03561
• Device Sequence Number: 14018660
• Product Code: EZL
• UDI-Device Identifier: 00827002143371
• UDI-Public: (01)00827002143371(17)181009(10)6274011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 10/09/2018
• Device Catalogue Number: 028006
• Device Lot Number: 6274011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1