MAUDE Adverse Event Report: COOK INC ULTRAXX NEPHROSTOMY BALLOON & SET; LJE CATHETER, NEPHROSTOMY

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient code: no known impact or consequence to patient.Device code: material/balloon rupture is addressed in the ifu.Blank fields on this form indicate the information is unknown or unavailable.The event is currently under investigation.
Event or Problem Description
It was reported a cook ultraxx nephrostomy balloon was used for a cystostomy catheter exchange and the balloon was inflated successfully at the target site.However, the balloon ruptured when the user advanced a supplied clear sheath over the balloon.Another manufacturer's device was used to complete the procedure.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation : a review of the complaint history, device history record, instructions for use (ifu), specifications, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: advance the sheath over the inflated balloon and into the proper position.The tolerances of the sheath and inflated balloon are very close.If resistance is encountered when advancing the sheath, it may be necessary to decrease balloon inflation to facilitate sheath passage.The visual inspection of the returned device reported the balloon has a circumferential split 2 cm from the proximal bond.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a physical evaluation confirmed that the balloon did rupture, however, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported a cook ultraxx nephrostomy balloon was used for a cystostomy catheter exchange and the balloon was inflated successfully at the target site.However, the balloon ruptured when the user advanced a supplied clear sheath over the balloon.Another manufacturer's device was used to complete the procedure.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON & SET
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5798015
• Report Number: 1820334-2016-00633
• Device Sequence Number: 341493
• Product Code: LJE
• UDI-Device Identifier: 00827002460379
• UDI-Public: (01)00827002460379(17)190204(10)6712251
• Combination Product (Y/N): N
• PMA/510(K) Number: K024050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2016

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 Model Number: N/A
• Device Catalogue Number: UNBS-6-15-CS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1