N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 5673412
- MDR report key
- 5673412
- Report number
- 1820334-2016-00338
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-01-07
- Date received
- 2016-05-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-23 | 0 | 1. O |
Event Narratives#
D
Patient 1
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.
N
Patient 1
(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.
D
Patient 1
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.