MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number	82-3832
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve was implanted in (b)(6) 2021.In mid february, the patient was not feeling good and on (b)(6) 2022 a revision surgery was done.The physician found that the joint part between the valve and the abdominal catheter was broken.Therefore, the valve was explanted and replaced.All parts were recovered.
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
Hakim valve was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined; however, the possible root cause could be due to a sharp or pointed object coming into contact with the device, as noted in the ifu, silicone has a low cut/tear resistance.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation.Device history record (dhr) - lot 4088573 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was 70mmh2o.The valve was visually inspected; the silicone housing at the point where the connector should be is damaged crushed/torn (possible due to a hard knock), marks were also noted on the connector.The complaint is confirmed.The root cause for the issue reported by the customer could be due to the valve receiving a hard knock damaging the silicone housing and breaking of the connector.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 13942886
• Report Number: 3013886523-2022-00122
• Device Sequence Number: 17759366
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(17)240831(10)4088573
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2022

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 Expiration Date: 08/31/2024
• Device Model Number: 82-3832
• Device Catalogue Number: 823832
• Device Lot Number: 4088573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 08/26/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/09/2022; 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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