MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER

Model Number	82-3074
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	05/16/2022
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: 3013886523-2022-00238.A physician reported a certas valve (828804) was implanted in a (b)(6)-year old female patient via l-p shunt on (b)(6) 2022 with unknown setting.It was used with bactiseal catheter (id 823074) (serial;unk) and the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2022 an mri examination was performed and ventricular enlargement was confirmed.An attempt was made to change the pressure, however, it was not possible.The patient had no clinical symptoms.On (b)(6) 2022 ventricular enlargement was confirmed again when an mri examination was performed.A shunt obstruction was suspected, therefore the valve was removed and replaced on (b)(6) 2022.The catheter was also removed and it is unknown if it was replaced.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10 the bactiseal catheter (id (b)(6) was returned for evaluation.Failure analysis the catheter was visually inspected and no defect was noted.The catheter passed the test for occlusion.The catheter was leak tested and no leak was noted no root cause could be determined as the technician could not confirm any problem with the valve 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 occluding the catheter, at the time of investigation no functional issues were noted.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• 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: 14567754
• Report Number: 3013886523-2022-00239
• Device Sequence Number: 14760393
• Product Code: JXG
• UDI-Device Identifier: 10886704041337
• UDI-Public: 10886704041337
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 82-3074
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/17/2022
• 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: 66 YR
• Patient Sex: Female