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

Model Number	G00166
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7072543
• Report Number: 1820334-2017-04313
• Device Sequence Number: 1004634
• Product Code: DRC
• UDI-Device Identifier: 00827002001664
• UDI-Public: (01)00827002001664(17)201118(10)6390551
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: G00166
• Device Catalogue Number: SDN-18-7.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 02/21/2018; 03/22/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/13/2018; 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1