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

Model Number G03750

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # k171764.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a hair-like fiber was found within the sterile packaging of a safe-t-j amplatz extra-stiff support wire guide.There was no patient involvement.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, a hair-like fiber was found within the sterile packaging of a safe-t-j amplatz extra-stiff support wire guide.There was no patient involvement.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, manufacturing instructions, and quality control data.The complainant returned safe-t-j amplatz extra-stiff support wire guide to cook for investigation.Physical examination of the returned device showed: one sealed device received.A hair like fiber was noted inside the sealed pouch.In response to this incident, cook reviewed the device history record.The dhr for the reported complaint device lot records one non-conformance reworked, one foreign matter and two non-conformances not relevant.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Although there has been a total of one lot related non-conformance for this failure mode, there are 100% inspections to capture this failure mode prior to distribution and there is objective evidence that the dhr was fully executed.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ cook has concluded manufacturing/quality control deficiency contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11979893
• MDR Text Key: 262209883
• Report Number: 1820334-2021-01498
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002037502
• UDI-Public: (01)00827002037502(17)260312(10)13763360
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G03750
• Device Catalogue Number: THSCF-32-260-3-AES
• Device Lot Number: 13763360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1