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

Model Number	G07515
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer name and address : (b)(6).G4: pma/510(k) number = k180054.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 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
As reported, "dust-like" foreign matter was found within an amplatz whisker extra-stiff support wire guide's package.This was observed within a distribution facility.The device was not used.
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, unchanged, or unavailable.Corrected information: h6 (annex a) summary of event: as reported, "dust-like" foreign matter was found within an amplatz whisker extra-stiff support wire guide's package.This was observed within a distribution facility.The device was not used.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Foreign matter was confirmed within the sealed packaging.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, there is no evidence of additional non-conforming devices in-house or in the field.100% inspections are in place to identify foreign matter within the sealed device packaging.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing and quality control deficiency caused this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• Brand Name: AMPLATZ WHISKER EXTRA-STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16988395
• Report Number: 1820334-2023-00639
• Device Sequence Number: 6957145
• Product Code: DQX
• UDI-Device Identifier: 00827002075153
• UDI-Public: (01)00827002075153(17)280220(10)15231186
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Model Number: G07515
• Device Catalogue Number: THSF-35-260-AESW
• Device Lot Number: 15231186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown