MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL BARIUM STRIPED CATH; BACTISEAL CATHETER KIT

Catalog Number NS0340

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

Patient Problem Cyst(s) (1800)

Event Date 11/14/2020

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 on (b)(6) 2020 the codman bactiseal catheter was connected to a certas small valve and implanted via v-p shunt with unknown settings for inph (idiopathic normal pressure hydrocephalus).After a month, no problems were noted via ct.A ct scan after 2 months noted a cyst around the connection of the proximal catheter and the valve (around the burr hole).The physician is watching the patient as there are no symptoms with this issue so far.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The bactiseal catheter was not returned for evaluation (per customer, 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.

Manufacturer Narrative

Unique device identifier (udi) :(b)(4).The bactiseal catheter was returned for evaluation: failure analysis - no defects noted on right angle adaptor and catheter.The catheter was irrigated and no occlusion was noted.The catheter was leak tested and no leakage noted.No root cause could be determined as the technician could not confirm any problem with the returned devices at the time of investigation.The possible root cause(s) of failure for ¿cyst was observed¿ could be due to patient's condition or patient's tissue reaction ("improper material choice").At the time of investigation no issues were noted with the devices.

Event Description

N/a.

• Brand Name: BACTISEAL BARIUM STRIPED CATH
• Type of Device: BACTISEAL CATHETER KIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10953924
• MDR Text Key: 219903719
• Report Number: 3013886523-2020-00235
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NS0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1