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

Catalog Number INS5010

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A neurosurgery account manager reported on behalf of the customer that the ins5010 hermetic lumbar catheter, closed tip guidewire was stripped on (b)(6) 2019.The customer rinsed the catheter, guidewire and spinal needle.They had a fairly large patient when they did the procedure and was able to get to the cerebrospinal fluid space.Everything went fine until they tried to pull the guidewire out that it stripped.There was no patient injury reported.Additional information received on 02aug2019 indicated that there was no surgery delay due to the product problem however they were unable to complete the catheter placement; the surgeon aborted that part of the procedure.

Event Description

N/a.

Manufacturer Narrative

Device identifier: 10381780071082, product identifier: (17)230204(10)3688508.One sample was received from the customer.It contained a catheter and guidewire.The lot number could not be confirmed since product original package was not included.Part of the guidewire was still inside the catheter.The unravelling of the wire was evident.The catheter was torn and pieces of wire could be seen through the tears/slits, evidencing that some force was used trying to pull the guidewire.This type of guidewire consists of two (2) wires.One of the wires is an inner straight wire and the other is the outer wire wound around the first one.A teflon coating is applied to the exterior surface of the guide wire which facilitates wire insertion and removal from catheter.A small portion (about 3 cm) of the inner wire end was exposed due to the unravelling of the outer wire.The internal wire measured about 100.8 cm long (which is about the length of the guidewire ¿ 1m).The rest of the outer wire that was left inside the catheter was pulled from the catheter.It came out with ease grabbing onto the catheter underneath the wire¿s end.The wire was not stuck inside the catheter.Once outside the catheter, the guidewire was examined and there was a section at the end of it in which the coiling was intact.This end was unraveled to photograph the point where the breakage occurred.It was observed that the inner wire had broken proximal to the distal weld.Device history record for lot: 3688508 was reviewed; no anomaly was found that could have caused the reported event.The complaint was confirmed since the guidewire was received unraveled; nonetheless, when the wire left inside the catheter was pulled, it came off with ease.This indicates that the wire was not stuck or trapped in any manner inside the catheter.The most probable cause for the breakage is excessive force used to retrieve the wire caused the breakage proximal to the distal weld.

• 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
• MDR Report Key: 8906052
• MDR Text Key: 191603720
• Report Number: 2648988-2019-00079
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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 Expiration Date: 02/04/2023
• Device Catalogue Number: INS5010
• Device Lot Number: 3688508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1