MAUDE Adverse Event Report: COOK INC TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G07304
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510 (k): preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The customer reported that a piece of micro wire from a torq-flex (b)(6) modification mandril wire guide was left in the right femoral area subcutaneously while the device operator was trying to get access femorally to patient.It is currently unknown if a retrieval of the fragment was attempted.
Additional Manufacturer Narrative
Additional information received identified a tavr (trans-catheter aortic valve replacement) was being performed when the event occurred.It was also reported the patient did not require any additional procedures due to this event.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, manufacturing instructions, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device manufacturing record was reviewed and no notable gaps in production or processing controls were noted.A review of the device history record shows one related nonconforming event, but the nonconforming devices were detected and scrapped in quality control.Thus, there is not enough evidence to suggest additional nonconforming devices in house or in the field.It should be noted there were no other reported complaints for this lot number.Instructions for use: l_scor_rev 0 is attached to the device and depicts a warning to not pull the distal spring coil portion of the wire guide through the needle tip.Based on the information provided, no product returned and the results of our investigation, the possible root cause was determined as known inherent risk of device since this failure mode has been previously observed with similar conclusions.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: TORQ-FLEX AUSTRALIAN MODIFICATION MANDRIL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7450099
• Report Number: 1820334-2018-01143
• Device Sequence Number: 144839
• Product Code: DXQ
• UDI-Device Identifier: 00827002073043
• UDI-Public: (01)00827002073043(17)230130(10)8504638
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G07304
• Device Catalogue Number: STF-18-40-AUST
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 08/16/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/16/2018; 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR