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

Model Number	NS0340
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2022-00317.A physician reported a certas valve (b)(4) was implanted via v-p shunt on (b)(6) 2022 with setting 2 and was used with bactiseal barium striped cath (ns0340).Due to suspicion of obstruction, shunt imaging was performed on an unknown date.There was no flow that could be confirmed on the distal part of the valve.The valve and catheter were removed (b)(6) 2022.The valve was replaced and it is unknown if the catheter was also replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10 the bactiseal catheter (id ns0340) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.The catheter was leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problem with the catheters at the time of investigation.The possible root cause for the issue reported by the customer could be due to user¿s error, possible when connecting the catheter, at the time of investigation no occlusion issues were noted with the catheter, or the defect could be with the valve.

• Brand Name: BACTISEAL BARIUM STRIPED CATH
• Common Device Name: BACTISEAL CATHETER KIT
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14991599
• Report Number: 3013886523-2022-00318
• Device Sequence Number: 1674177
• Product Code: JXG
• UDI-Device Identifier: 10886704045175
• UDI-Public: 10886704045175
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NS0340
• Device Catalogue Number: NS0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female