MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA NEURO BALLOON CATHETER; NEUROENDOSCOPY

Model Number	7CBD10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the neuro balloon catheter (7cbd10) was tested before use according to the instructions, but the balloon was broken during use.No patient injury or death alleged and the event did not lead to an increase of surgery time.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The neuro balloon catheter (7cbd10) was returned for evaluation: device history record (dhr): the device history records of ref 7cbd10, lot 224496 were reviewed and did not reveal any anomaly that could explain the reported event.Failure analysis - the investigation of the returned device was unable to verify customer reported issue as valid.Visual inspection of the received neuroballoon catheter revealed no anomaly.Functional testing verified inflation deflation was correct (proximal side inflates before distal side), inflation was maintained over 1 minute, no leak was detected, no damage was observed.Root cause - complaint was not verified on the returned device, and the product was functional.Silicone elastomer balloon was not broken and did not leak.The exact cause of the reported malfunction could not be determined by the investigation.Given the investigation results, no further investigation nor corrective action is deemed required.

• Brand Name: NEURO BALLOON CATHETER
• Common Device Name: NEUROENDOSCOPY
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13257857
• Report Number: 9612007-2022-00001
• Device Sequence Number: 4663317
• Product Code: HAO
• UDI-Device Identifier: 10381780035343
• UDI-Public: 10381780035343
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 07/07/2023
• Device Model Number: 7CBD10
• Device Catalogue Number: 7CBD10
• Device Lot Number: 0224496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown