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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
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.
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.

• 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: 5673412
• Report Number: 1820334-2016-00338
• Device Sequence Number: 16148221
• Product Code: FAP
• UDI-Device Identifier: 00827002155404
• UDI-Public: (01)00827002155404(17)180120(10)5591641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K915443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 020707-B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2016
• Device Age: 1 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other