MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, OPEN TIP; N/A

Catalog Number	INS8330
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is for the 2nd of 2 tips used on the same patient and linked to mfg report number 2648988-2024-00002: a facility reported that the tip of the hermetic lumbar catheter, open tip (ins8330) was retained and and broke inside a patient.There was increased surgery time of 15 minutes.Additional information has been requested.
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.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h3, h10 the hermetic lumbar catheter, open tip (ins8330) was not returned for evaluation as the product was "cut" per customer: device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed, and no anomaly was observed that could be related to the reported condition.Failure analysis - product was not returned and no picture showing the reported condition was provided; therefore, failure analysis is not possible.There are no details as to what was happening when ¿tip of catheter was retained and broke inside the patient¿ (e.G., during insertion, catheter repositioning, was the tuohy needle still in place, any patient¿s preexisting characteristic that may have contributed to the reported event).Root cause - the root cause determination is not possible at this moment.However, based on the risk documents, a potential root cause for the reported condition could be that the physician inadvertently tore the silicone with the stylet, guidewire, or tuohy needle.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 additional information was received as follows: 1.If the surgery time was increase of 15 minutes for each catheter or for both? >>in total.It was in the same patient.2.Did they manage to retrieve the broken part in the patient? >>yes 3.How did they finish the surgery? >> using another catheter.4.Was the patient a child, a teenager, an adult, an elderly person? >>adult patient investigation findings: hermetic lumbar catheter, open tip (ins8330) was not returned for evaluation as the product was "cut" per customer; therefore, failure analysis is not possible.In addition, no picture showing the reported condition was provided.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.There are no details as to what was happening when ¿tip of catheter was retained and broke inside the patient¿ (e.G., during insertion, catheter repositioning, was the tuohy needle still in place, any patient¿s preexisting characteristic that may have contributed to the reported event).Therefore, a root cause determination is not possible at this moment.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.
Event or Problem Description
N/a.

• Brand Name: HERMETIC LUMBAR CATHETER, OPEN TIP
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18505304
• Report Number: 2648988-2024-00003
• Device Sequence Number: 15440819
• Product Code: JXG
• UDI-Device Identifier: 10381780026211
• UDI-Public: 10381780026211
• Combination Product (Y/N): N
• PMA/510(K) Number: K972994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: INS8330
• Device Lot Number: 6926417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 01/17/2024; 02/21/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/01/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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: Unknown