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

Model Number	G03203
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	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was observed inside the sealed packaging of an amplatz extra stiff support wire guide.This was noticed by a nurse prior to opening, so another unknown device was used to complete the procedure.The complaint device was stored vertically and there was no damage to the packaging.A photo of the complaint device provided by the customer confirms a human hair-like fiber inside the sealed package.As reported, the device did not make patient contact and no harm has been reported.
Additional Manufacturer Narrative
E1 -postal code: (b)(6).G4- pma/510(k) #: k171764.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.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that foreign matter was observed inside the sealed packaging of an amplatz extra stiff support wire guide.This was noticed by a nurse prior to opening, so another unknown device was used to complete the procedure.The complaint device was stored vertically and there was no damage to the packaging.A photo of the complaint device provided by the customer confirms a human hair-like fiber inside the sealed package.As reported, the device did not make patient contact and no harm has been reported.Reviews of the documentation, including the complaint history, device history record, quality control procedures, as well as visual inspection of the returned product, were conducted during the investigation.One sealed/unused device was received (wire guide).A hair like fiber was noted sealed in the pouch.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review the device labeling, as an ifu pamphlet is not included with the complaint device.Evidence gathered upon review of returned device indicates the device was manufactured out of specification.However, review of the dmr and dhr suggests that there are no additional nonconforming devices in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, cook concludes this event is due to a manufacturing quality control deficiency.Per the risk assessment no further action is required.The appropriate personnel have been notified.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.

• Brand Name: AMPLATZ 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: 19785933
• Report Number: 1820334-2024-00986
• Device Sequence Number: 8068537
• Product Code: DQX
• UDI-Device Identifier: 00827002032033
• UDI-Public: (01)00827002032033(17)290305(10)15930587
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: G03203
• Device Catalogue Number: THSCF-35-145-3-AES
• Device Lot Number: 15930587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown