MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE RIGHT ANGLE W SG; CHPV WITH SG

Catalog Number 823182

Device Problem Output Problem (3005)

Patient Problem Injury (2348)

Event Date 12/03/2020

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

A physician reported that the valve was implanted on (b)(6) 2020 and on (b)(6) 2020, they performed brain mri with the 3t system and at subsequent attempts to calibrate the valve at 130 mmh2o the calibrator never gave the correct calibration signal, and the fluoroscopy control was blocked at 70 mmh2o.There were other attempts to reset the valve, but it was unable to reach the 130 mm h2o opening.There was a surgical delay of 3 hours due to product problem.The valve was explanted on (b)(6) 2020.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10.Udi : (b)(4).The valve was returned for evaluation: the valve was visually inspected, no defects noted.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be biological debris and protein build up interfering with the valve mechanism, at the time of the investigation no functional issues were noted.

Event Description

N/a.

• Brand Name: PROG VALVE RIGHT ANGLE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• MDR Report Key: 11074138
• MDR Text Key: 224036225
• Report Number: 3013886523-2020-00282
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 823182
• Device Lot Number: 4560702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/27/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1