URODYNAMICS BALLOON CATHETER N/A 020707-B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-23 for URODYNAMICS BALLOON CATHETER N/A 020707-B manufactured by Cook Inc.

Event Text Entries

[45747535] (b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10


[45747536] During a cystometry and urethral pressure profilometry procedure. The balloon broke (ruptured) while within the patient. There is concern that there may be some fragments left inside patient. It is unknown if there have been any adverse effects at this time or the condition of the patient. No additional information can be provided as the individual who originally reported the incident has since retired. Additional information has been requested but not yet provided by the reporter.
Patient Sequence No: 1, Text Type: D, B5


[54093760] (b)(4). Investigation / evaluation: no product was returned as information was provided that the customer disposed of the device. However, during the course of investigation, a review of the complaint history, device history record, documentation, quality control (qc) and specifications was conducted. Due to the complaint device not being returned, a physical examination of the complaint device could not be performed. The device history record was reviewed and no non-conformances were noted. In accordance with manufacturing controls, product is 100% leak tested for balloon integrity and functionality. A review of the lot documentation for the product in this case did not observe any nonconformance or issues that may have contributed to the failure mode in this case. Per the provided ifu, it cautions: "do not overinflate the balloon". This product is 100% leak tested for balloon integrity and functionality. A review of records revealed this complaint to be the only reported complaint associated to the provided complaint lot number. As a conservative approach, cook is confirming the rupture of the balloon and fragmentation left behind within the patient with an assumed necessary secondary procedure to retrieve fragments. Based on the provided level of information, a definitive root cause can not be determined or reported at this time. We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event. Per the quality engineering risk assessment (qera), no additional risk mitigation activities required at this time.
Patient Sequence No: 1, Text Type: N, H10


[54093761] During a cystometry and urethral pressure profilometry procedure. The balloon broke (ruptured) while within the patient. There is concern that there may be some fragments left inside patient. It is unknown if there have been any adverse effects at this time or the condition of the patient. No additional information can be provided as the individual who originally reported the incident has since retired. No additional information has been provided regarding patient outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2016-00338
MDR Report Key5673412
Report SourceCOMPANY REPRESENTATIVE
Date Received2016-05-23
Date of Report2016-04-27
Date of Event2016-01-07
Date Facility Aware2016-01-07
Date Mfgr Received2016-04-27
Device Manufacturer Date2015-01-20
Date Added to Maude2016-05-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. RITA HARDEN
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURODYNAMICS BALLOON CATHETER
Generic NameFAP CYTOMETRIC GAS (CARBON DIOXIDE
Product CodeFAP
Date Received2016-05-23
Model NumberN/A
Catalog Number020707-B
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-05-23

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