MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LARGE STYLE VENTRICULAR CATHETER SET; N/A

Catalog Number INS4500

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 07/09/2017

Event Type  Injury  

Event Description

During ventriculostomy replacement, the tip of the ventricle tube was found to be missing on retrieval.Upon ct scan, the 1.5 cm tip was found in the patient on imaging.Additional information received from the customer 15aug2017: the customer stated that "this was not a replacement catheter per se".The patient had an evd on the right side that was approximately two weeks in place.Our standard protocol calls for placing an entirely new catheter after two weeks through a different incision in order to avoid infection.It was this second catheter that was being inserted through a fresh incision on the left side of the patient.It was inserted because of hydrocephalus secondary to aneurysmal subarachnoid hemorrhage on the (b)(6) female patient.The procedure was done using usual surgical technique for placement of an evd.The patient's scalp was shaved, prepped and draped.Local anesthesia with sedation was used.A small stab incision was made and a twist drill hole turned.The dura was opened.The catheter was targeted toward the ventricle and inserted without difficulty.Because of the lack of return of spinal fluid at 5 cm.Of depth, the catheter was withdrawn to be reinserted.It was at that point the tip was noted to be missing from the catheter after the initial pass to the patient's ventricle.The pass was off target.The catheter was withdrawn to retarget the ventricle.The tip however was immediately noticed to be missing and a new catheter was used.There was no harm to the patient.However, it was decided not to retrieve the tip; it was left in place.It was decided not to retrieve the tip due to the invasive nature of such a procedure.It would have required a craniotomy.The catheter is not available to be returned for evaluation; it was believed to be discarded.Lot number: 1165009 or 1170088.Sus voluntary report# mw5071053.

Manufacturer Narrative

Investigation completed 10/26/2017.Device history record (dhr) of manufacturing lots 1165009 or 1170088 of hermetic large style ventricular catheter set was reviewed.No anomalies were found that could be related to the described failure.No sample has been received for failure analysis (discarded); therefore, the sample is unconfirmed.No unusual event related to the reported failure was noticed during the records review of this lot.According to the information sent by the customer: ¿the tip was noticed to be missing from the catheter after the initial pass to the patient's ventricle.The pass was off-target.The catheter was withdrawn to retarget the ventricle.The tip however was immediately noticed to be missing and a new catheter was used.¿ it is unknown the procedure used to withdraw the catheter to ¿retarget¿ it.The ifu provides the following warning: ¿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.¿ there are procedural controls and in-process verifications to prevent this type of defect during the manufacturing process.The most probable cause for this event is related to catheter ¿retargeting¿ procedure where the catheter may have been cut with the tuohy needle while withdrawing the catheter.

• Brand Name: HERMETIC LARGE STYLE VENTRICULAR CATHETER SET
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6810998
• MDR Text Key: 83258448
• Report Number: 2648988-2017-00030
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INS4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• 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
• Patient Outcome(s): Other