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

Catalog Number	823074
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Fever (1858); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers: 3013886523-2023-00266 3013886523-2023-00267 a facility reported a hakim valve (id 823832) was implanted along with the ventricular catheter (id 823073) and peritoneal catheter (id 823074) on (b)(6) 2023.On (b)(6) 2023, the physician found that the catheter was obstructed and the patient had an infection.The patient had fever at 38.5 and high blood pressure.A cerebrospinal fluid (csf) testing indicated the nucleated cell count was above the normal level.Therefore, the physician removed all the products on (b)(6) 2023, but not yet replaced.The patient's health history is hydrocephalus.The patient is now with the normal body temperature.
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
N/a.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (823074) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined, however, the possible root cause for the ¿obstruction;¿ issues reported by the customer, could be due to biological debris occluding the catheter or a kink in the catheter.The possible root cause for the ¿infection¿ reported by the customer, could be linked to the patient and hospital surroundings.¿ if additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.B5 correction: initial mdr states: on (b)(6), 2023, the physician found that the catheter was obstructed and the patient had an infection.Correction: on (b)(6), 2023, the physician found that the catheter was obstructed and the patient had an infection.

• 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: 17551621
• Report Number: 3013886523-2023-00268
• Device Sequence Number: 20497512
• Product Code: JXG
• UDI-Device Identifier: 10381780515630
• UDI-Public: (01)10381780515630(17)230430(10)6331373
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 823074
• Device Lot Number: 6331373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 08/30/2023
• Date Device Manufactured: 05/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HAKIM VALVE (ID (B)(6)); VENTRICULAR CATHETER (ID (B)(6))
• Patient Sex: Unknown