MAUDE Adverse Event Report: COOK INC ONE-PART PERCUTANEOUS ENTRY NEEDLE; DRC TROCAR

Model Number G00166

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during an aortogram with left lower extremity run-off, the one-part percutaneous entry needle was flushed and used to gain access to the patient's groin.Another manufacturer's 0.035 inch diameter glidewire was then inserted through the entry needle and a shearing effect was noted.Part of the glidewire was dissected by the entry needle; a sliver of material was recovered from the patient when removing the entry needle and glidewire.The patient did not require any additional procedures due to this occurrence; no adverse effects to the patient have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed; however, imaging was provided for review.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The photograph depicts a coated 0.035 inch diameter terumo glidewire partially inserted through the one-part percutaneous entry needle.There is a fully separated section of wire coating in the image which is approximately half the length of the needle.A portion of the wire coating has been partially peeled, and extends approximately half the length of the needle.It remains connected to the distal tip of the wire.The bevel of the needle is pushed as far forward as the point here the coating separation begins, giving the appearance that the wire was withdrawn through the needle.Based on the needle's specified dimensions and the specified dimensions of the stylet checker, a 0.035 inch diameter wire should fit through the lumen of this needle without difficulty within normal use, although we do not have diameter and tolerance information for the terumo glidewire.The mdx-silicone coating of the needle may also serve to facilitate passage.The needle is inspected for dents and burrs during the manufacturing process, and the stylet checker must pass freely through the lumen with a smooth transition.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined; however, it is likely that this event can be attributed to handling/ user technique as it appears that the coated wire was withdrawn through the needle.Risk assessment was not performed as there is no indication based on available information that the one-part percutaneous entry needle malfunctioned, was defective, or not manufactured to specification.Monitoring will continue to be performed for similar complaints.

• Brand Name: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7215900
• MDR Text Key: 98121423
• Report Number: 1820334-2018-00227
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002001664
• UDI-Public: (01)00827002001664(17)221102(10)8343168
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G00166
• Device Catalogue Number: SDN-18-7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention