MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT

Model Number	82-3072
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Headache (1880)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
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
This is 2 of 2 reports linked to mfg report number: 3013886523-2021-00567.A physician reported a certas valve (828804) and a bactiseal catheter kit (823072) were implanted in a (b)(6) year-old male patient via v-p shunt on (b)(6) 2021 with valve setting 4.The patient developed headache and valve obstruction was suspected.Shunt contrast was performed on (b)(6) 2021 and obstruction in the abdominal side was observed.The valve and catheter were removed on (b)(6) 2021, and have not been replaced.The symptoms improved after removal.
Additional Manufacturer Narrative
The codman bactiseal catheter kit was returned for evaluation.Failure analysis - the 30mm bactiseal peritoneal catheter was visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.No root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device at the time of investigation the no occlusion issues were noted with the catheter.
Event or Problem Description
N/a.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: BACTISEAL CATHETER KIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13236465
• Report Number: 3013886523-2022-00008
• Device Sequence Number: 19970211
• Product Code: JXG
• UDI-Device Identifier: 10886704041313
• UDI-Public: 10886704041313
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 82-3072
• Device Catalogue Number: 823072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 12 YR
• Patient Sex: Male