MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV UNITIZED

Catalog Number 823114

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

Patient Problems Cyst(s) (1800); Injury (2348)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The 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.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.

Event Description

A post-market clinical program reported that on (b)(6) 2018 the patient received a ventriculoperitoneal shunt procedure.On (b)(6) 2018, the patient went to the hospital and said there are two lumps (arachnoid cyst) on the head ever since the procedure.The patient received a revision procedure to retrieve the device and which was changed with a new catheter the same day.

• Brand Name: MICRO CHPV UNITIZED
• Type of Device: CHPV
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6099362319
• MDR Report Key: 10298697
• MDR Text Key: 202704684
• Report Number: 1226348-2020-00347
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 823114
• Device Lot Number: CVHBWT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Date Device Manufactured: 06/22/2016
• 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