MAUDE Adverse Event Report: COOK INC URODYNAMICS BALLOON CATHETER; FAP CYTOMETRIC GAS (CARBON DIOXIDE

Catalog Number	020707-B5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2016
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 during the use of urodynamics balloon catheter for cystometry studies, the balloon "exploded".It was further noted that the balloon material was split from proximal bond to distal bond.There were no adverse effects reported due to the event and no report of an additional procedure.A new product was used.

• Brand Name: URODYNAMICS BALLOON CATHETER
• Common Device Name: FAP CYTOMETRIC GAS (CARBON DIOXIDE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8116653
• Report Number: 1820334-2018-03581
• Device Sequence Number: 11134605
• Product Code: FAP
• UDI-Device Identifier: 00827002169876
• UDI-Public: (01)00827002169876(17)181211(10)6447907
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 12/11/2018
• Device Catalogue Number: 020707-B5
• Device Lot Number: 6447907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1