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

Model Number G00166

Device Problem Bent (1059)

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

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during an angioplasty, the tip of the one-part percutaneous entry needle was bent and incompatible with the associated product model.According to the initial reporter, the needle did not come into contact with the patient.The patient did not require any additional procedures due to this occurrence, nor did the patient experience any adverse effects due to this occurrence.

Manufacturer Narrative

A photograph of the device was received from the customer.A photographic inspection was performed, and the results were included in the investigation.Investigation - evaluation : a review of the device history record, drawing, manufacturing instructions, quality control, and a photographic inspection were conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a photograph of the complaint device was received for evaluation.The photo shows a needle that is bent close to the distal end.Additionally, a document-based investigation was performed.The manufacturing documents in place at the time of the event were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.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.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

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, a document-based investigation was performed.The manufacturing documents in place at the time of the event were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.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.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is required.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7072543
• MDR Text Key: 93869750
• Report Number: 1820334-2017-04313
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00827002001664
• UDI-Public: (01)00827002001664(17)201118(10)6390551
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2018

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 Model Number: G00166
• Device Catalogue Number: SDN-18-7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 02/21/2018; 03/22/2018
• Supplement Dates FDA Received: 03/13/2018; 04/17/2018
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1