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

Catalog Number INS5010

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Device Operates Differently Than Expected (2913)

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

Event Date 04/01/2016

Event Type  malfunction  

Event Description

This is the second of two reports (same facility, same product problem, different product id).Linked to mfr report: 9612007-2016-00011.Reports were received for the 910121 lumbar catheter and the ins5010 catheter having issues with the placement.On (b)(6) 2016, the physician could not withdraw the guide wire from the silicone catheter without it crimping.He confirmed that he had both irrigated the catheter and guide wire (in the case of the 910121) just prior to placement.He could not remove the silicone catheter from the tuohy needle, once it was inserted into the patient, without concern of the tip being sheered off and left lodged in the patient.The product problems led to a 15 minute increase in surgery time.The patient was not harmed or injured as a result of the incident.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 03 jun 2016.The product was not returned for evaluation.The device history record (dhr) could not be reviewed since the fg lots were not provided.Approximately (b)(4) units were released for distribution from may 2014 to may 2016.Therefore, the complaint occurrence rate for this type of incident is (b)(4).This was determined by dividing the number of complaints in this category (b)(4) by the number of units released for distribution purposes (b)(4) times 100.The residual risk associated with this harm is deemed acceptable since the current occurrence rate ((b)(4)) is less than 0.1% for likelihood of occurrence.Conclusion: the clinically applied product was not returned for evaluation; therefore, the specific cause for the problem reported could not be identified.If additional information is obtained, or the sample is returned, this investigation will be reopened.As for the first reported condition (the doctor could not withdraw the guide wire from the silicone catheter without it crimping.He confirmed that he had both irrigated the catheter (and guide wire in the case of (b)(4)) prior to placement), no assignable causes that could be associated to the manufacturing process were determined based on the review of capa's, ncr's and scar's history.As per the product¿s design, the stainless steel guide wire is coated with teflon®.Teflon® has a low coefficient of friction (mechanical property), which would allow for ease of guide wire insertion and removal from catheter.On the second reported condition (the doctor could not remove the silicone catheter from the tuohy needle once inserted in to the patient, without concern of the tip being sheared off and left lodged in the patient), it appears to be related to incorrect device handling since the catheter is never supposed to be removed from tuohy needle.Ifu states the following: to avoid possible transection of the lumbar catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guide wire if used) must be removed simultaneously.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5701881
• MDR Text Key: 47903238
• Report Number: 2648988-2016-00025
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K970658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1