MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Catalog Number	823842
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
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
A physician reported a bactiseal peritoneal catheter (id 823074) was implanted via ventriculoperitoneal (vp) shunt on an unknown date.The catheter was detached, therefore it was removed and replaced on an unknown date.According to information provided, it is unknown if the patient experienced any signs and symptoms due to product failure.
Additional Manufacturer Narrative
Additional information received: "it was reported that the valve was implanted to the patient via ventriculoperitoneal shunt in (b)(6) 2017 with unknown setting.A rupture of the distal catheter was confirmed through diagnostic imaging during prostate surgery.Only the distal catheter fragment was recovered during prostate surgery.No catheters were replaced.There is no residue in the patient's body.The valve remained in place.Since obstruction was suspected, the valve was removed on (b)(6) 2023.As the patient's condition is stable, there are no plans for replacement.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id (b)(4)) was returned for evaluation.Failure analysis - the valve was visually inspected, a needle hole in the needle chamber was noted.The proximal connector was missing.The position of the cam when valve was received was (b)(4).The valve was hydrated.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.It was possible to attach a connector to the proximal end.The valve was leak tested; no leaks were noted.The catheters were irrigated, no occlusions noted.The valve was dried.The siphon guard was removed.The proximal catheter was visually inspected, and signs of the catheter being attached to the connector were noted.The silicone housing where the connector should be, showed no signs of damage.Root cause analysis- the root cause for the missing proximal connector could be due to user¿s error.However, it was not possible to confirm and identify the root cause of this assumption as the connector was not returned for investigation.The possible root cause for the occlusion could be due to the disconnection of the proximal connector and catheter causing a leakage of cerebrospinal fluid into unintended parts of the body.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17738086
• Report Number: 3013886523-2023-00311
• Device Sequence Number: 15090925
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: 10886704041856
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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 Catalogue Number: 823842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 11/16/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 09/29/2023; 12/01/2023
• 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