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

Model Number	82-3045
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2022-00437 a physician reported a certas valve (id 8228814) was implanted due to snph (secondary normal pressure hydrocephalus) via vp shunt on (b)(6) 2022 with setting 5.It was used with hakim periton cath (id 823045).On (b)(6) 2022, patient hydrocephalus worsened.The set pressure of the valve could not be changed.A cerebrospinal fluid test showed a high protein concentration of 173 mg/dl.The physician tried to pass water through the peritoneal catheter during the surgery and the flow was poor.Therefore, the valve and the peritoneal catheter were removed and replaced on (b)(6) 2022.
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.
Additional Manufacturer Narrative
The hakim peritoneal catheter (id 823045) was returned for evaluation.Failure analysis - the catheters were irrigated no occlusions noted.No root cause could be determined as the technician could not confirm any problem with the small pieces of catheter returned.The possible root cause could be due to valve as this complaint is in connection with (b)(4).

• 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: 15464942
• Report Number: 3013886523-2022-00438
• Device Sequence Number: 6842370
• 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: 2022
• 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): 12/01/2022

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: 82-3045
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 12/01/2022
• 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 Sex: Female