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

Catalog Number 823073

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The bactiseal catheter was not returned for evaluation.Udi: (b)(4).The catheter 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.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for the issue reported by the customer could be due to user error as noted in the ifu silicone has a low tear/cut resistance, or wrong product prepared for the operation, 82-3088 instead of 82-3073.

Event Description

A physician reported an incorrect packaging of a bactiseal ventricular catheter.The product code the physician opened, 82-3073, was described as an open-ended catheter with slits at the end that the stylet stuck out of and should have been solid.The wrong bactiseal catheter was in two boxes that were opened for the case: both catheters with the same lot number, 4178253.The physician reported the catheter appeared to look just like the bactiseal endoscopic ventricular catheter, 82-3088.The incorrect catheter was placed in the patient for a ventricular peritoneal shunt placement.Post-operative mri imaging demonstrated the catheter was not correctly in the ventricle.The patient returned to the operating room and had the catheter replaced with the correct bactiseal ventricular catheter, 82-3073.

Event Description

N/a.

Manufacturer Narrative

The bactiseal catheter was not returned for evaluation nevertheless, a video was provided.Device history record (dhr) - review of the history device records for the product code 82-3073 with lot 4178253, conformed to the specifications when released to stock on the 25th june 2020.Failure analysis - the video clearly show that the stylet can pass through the catheter because of an opening at the tip side.The retained samples of the involved lot number (4178253) have been inspected and confirmed that the catheters had a slitted tip whereas they should be closed for this product code 82-3073.The investigation concluded that a mix-up between the batch involved in this complaint (code 82-3073, lot number 4178253) and another batch (code 82-3087, lot number 4178257) occured during impregnation process.The main root cause was a human application error; the two product codes for bactiseal treated in the same time as it is required by the working procedure, and lot traveler records were crossed (mixed-up).The second root cause is a process missing requirement.A corrective action have been opened to treat this issue.

• 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
• MDR Report Key: 10465898
• MDR Text Key: 204999152
• Report Number: 3013886523-2020-00064
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 823073
• Device Lot Number: 4178253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1