MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL VENTRICULAR CATHETER

Catalog Number 823073

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/02/2021

Event Type  Injury  

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 Description

1 of 3 reports.Other mfg report number: 3013886523-2021-00509, 3013886523-2021-00510.A facility reported a hakim valve (id 823832), a bactiseal ventricular catheter(823073) and a bactiseal peritoneal catheter (id 823074) were implanted in a (b)(6) year-old male patient on (b)(6) 2021.An infection was found on 2021 during a follow up visit.A complete blood count (cbc) and cerebrospinal fluid testing were performed and type of organism is unknown.The valve and both catheters were retrieved on (b)(6) 2021.After antibiotic therapy, the products will be replaced.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The bactiseal catheter (id 823073) was not returned for evaluation as the product was discarded as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined; however, the possible root cause for the issue reported by the customer could be linked to the patient and hospital surroundings.A review of the sterilization certificate conformed to the specifications when released on the 16th march 2021.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 Description

N/a.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Type of Device: BACTISEAL VENTRICULAR CATHETER
• 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: 12851135
• MDR Text Key: 281085143
• Report Number: 3013886523-2021-00508
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 823073
• Device Lot Number: 4302832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 03/09/2022
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male