MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Catalog Number 823045

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

2 of 2 reports.Other mfg report number: 3013886523-2021-00226.A physician reported that in 2001, a codman hakim programmable valve was implanted to a (b)(6) year-old female patient via v-p shunt with a setting of 100 mmh20.On (b)(6) 2021, the patient complained of a headache.Confirmation via mri showed that the catheter had fallen off and a slit-like ventricle was noted.Only the valve was replaced on (b)(6) 2021.The implanted abdominal catheter was extended by using a connector (823053) and bactiseal (823073).The cause of the deviation of the abdominal catheter was the increase in height of the patient and the occurrence of gravitational force.The patient¿s condition had improved.

Manufacturer Narrative

The catheter was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: HAKIM PERITON CATH,120CM
• Type of Device: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11854388
• MDR Text Key: 251663128
• Report Number: 3013886523-2021-00227
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K944222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR