MAUDE Adverse Event Report: COOK INC SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G03460
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code- dqx wire, guide, catheter.Occupation- materials manager.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
As reported, a hair was observed inside the sealed product packaging of a safe-t-j amplatz extra-stiff support wire guide.This was discovered when taking the device off a shelf for a procedure.The device did not make patient contact.Another device was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event summary ft.Sanders-park west hospital informed cook of an incident involving a safe-t-j amplatz extra-stiff support wire guide from lot 13707511.While pulling the product off the shelf for a procedure, the customer noticed a hair within the packaging.Another product was used to complete the procedure, with no harm reported.Investigation ¿ evaluation a review of the complaint history, device history record, manufacturing instructions and quality control, procedures of the device, as well as a visual inspection of the returned device, were conducted during the investigation.The complainant returned one sealed wire guide.Upon visual inspection, a dark fiber in the bottom seal of the pouch was noted.The device was confirmed to have been packaged out of specification.A device master record (dmr) review was performed, and device specifications, and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.An instructions for use (ifu) pamphlet is not supplied with the reported device; therefore, no review of labeling was conducted.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, cook conclude that no additional nonconforming product from this lot exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that a manufacturing and quality deficiency contributed to the failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: d2a, and d2b.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11607097
• Report Number: 1820334-2021-01056
• Device Sequence Number: 3535724
• Product Code: DQX
• UDI-Device Identifier: 00827002034600
• UDI-Public: (01)00827002034600(17)260218(10)13707511
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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: No Information
• Device Expiration Date: 02/18/2026
• Device Model Number: G03460
• Device Catalogue Number: THSCF-35-260-3-AES
• Device Lot Number: 13707511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 05/11/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/06/2021; 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1