MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM VENTRICULAR CATH; STANDARD CATHETERS

Catalog Number 823041

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injury (2348); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

2 of 3 reports.Other mfg report numbers: 3013886523-2020-00105, 3013886523-2020-00113.A physician reported the patient had clinical signs of an allergic reaction after the certas valve implantation.Therefore, the shunt system was removed in (b)(6) 2020.The valve was connected to hakim ventricular catheter (product#823041/lot#unk) and hakim abdominal catheter (product#823045/lot#unk).

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).Hakim catheter was not returned for evaluation 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.

• Brand Name: HAKIM VENTRICULAR CATH
• Type of Device: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10550692
• MDR Text Key: 207510291
• Report Number: 3013886523-2020-00112
• 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
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1