MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. BACTISEAL BARIUM STRIPED PERIT CATH; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS0339

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the sales rep, a bactiseal catheter fractured and was removed and replaced approximately three years after implantation.The catheter had been implanted along with a shunt, no further detail is available regarding the type of shunt.There are no reported symptoms for the patient associated to this event.

Manufacturer Narrative

Corrected field: (b)(4).It was previously reported that the device would be returned for evaluation, it was later communicated that the sample would not be provided.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.

• Brand Name: BACTISEAL BARIUM STRIPED PERIT CATH
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7583495
• MDR Text Key: 110523782
• Report Number: 1226348-2018-10398
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: NS0339
• Device Lot Number: 626198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention