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

Model Number	82-3045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Cerebral Ventriculomegaly (2133); Ambulation or Postural Difficulties (2544)
Date of Event	03/22/2022
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 numbers: 3013886523-2022-00171.Same patient, same event, different products.The physician reported a certas valve (id 828804) was implanted in a (b)(6) female patient via "l-p shunt" on (b)(6) 2021 with setting 5.The valve was used with a 823045 (serial: unk) and the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2021 the patient complained of headache, the set pressure of the valve was changed to setting 7 and symptom improved.On (b)(6) 2022 , the patient had a gait disorder and set pressure was changed to setting 2.The patient's symptoms did not improve and ventricular enlargement was observed.The valve, peritoneal catheter (823045) and the silascon lumbar catheter were removed on (b)(6) 2022.A rupture of the lumbar catheter was confirmed at the time of removal.The valve was replaced via "v-p shunt" on (b)(6) 2022.
Additional Manufacturer Narrative
The hakim peritoneal catheter was returned for evaluation.Failure analysis - the catheters were visually inspected; no defects were noted.All ends for the catheters seem to be clean cut.The catheters were irrigated no occlusions noted.The catheters were leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problem with the catheters at the time of investigation.The possible root cause for the issue reported by the customer could be due to user¿s error, possible when connecting the catheters, at the time of investigation, no occlusion issues were noted with the catheters.

• 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: 14159924
• Report Number: 3013886523-2022-00172
• Device Sequence Number: 2846009
• 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: 2021
• 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): 06/09/2022

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: 03/31/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/09/2022
• 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: 60 YR
• Patient Sex: Female