MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Model Number	82-3045
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2023
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
2 of 2 reports.Other mfg report number: 3013886523-2023-00013.A physician reported a certas valve (id (b)(6) was implanted due to sah (subarachnoid hemorrhage) via l-p shunt on (b)(6) 2022 with unknown setting.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj) and 823045 (hakim peritoneal catheter.Since the hydrocephalus got worse, the set pressure of the valve was lowered to 3 on unknown date.A patency check showed that the valve response was slow, so when the contrast medium was flowed, it flowed only in the direction of the lumbar catheter.Obstruction was suspected, therefore, the valve was removed on (b)(6) 2023.Based on information provided, it is unknown if the patient experienced signs and symptoms of valve malfunction.
Additional Manufacturer Narrative
The hakim peritoneal catheter (id 823045) was returned for evaluation.Failure analysis- the catheter is to short for any investigation.No root cause could be determined as the technician could not do any test with the short 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 catheter or could be due a kink in the catheter.
Event or Problem Description
N/a.

• Brand Name: HAKIM PERITON CATH,120CM
• Common Device Name: STANDARD CATHETERS
• 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: 16241584
• Report Number: 3013886523-2023-00014
• Device Sequence Number: 20471286
• Product Code: JXG
• UDI-Device Identifier: 10886704041276
• UDI-Public: 10886704041276
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 05/10/2023

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 Model Number: 82-3045
• Device Catalogue Number: 823045
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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 Sex: Unknown