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

Model Number	N/A
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code: dqx wire, guide, catheter.Occupation: inventory specialist.Pma/510(k) number: pre-amendment.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, upon opening the package prior to an unknown procedure, the safety wire was found to be protruding from the side of an amplatz extra-stiff support wire guide as it was pulled from the storage tubing.The device did not make contact with the patient.Another device of the same type was used to complete the procedure.The packaging was not damaged.
Additional Manufacturer Narrative
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
Description of event: as reported, upon opening the package prior to an unknown procedure, the safety wire was found to be protruding from the side of an amplatz extra-stiff support wire guide as it was pulled from the storage tubing.The device did not make contact with the patient.Another device of the same type was used to complete the procedure.The packaging was not damaged.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, and quality control data.The complainant returned the wire guide to cook for investigation.Physical examination of the returned device showed: one prior to use wire guide was received.Inspection found the mandril protruding at 4.3cm from the distal weld, and the distal end appeared to have been manipulated, possibly hand curved.No additional damage was noted.At this time, cook concluded that the device was manufactured within specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.This device is not supplied with an instruction for use (ifu).A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded transport/storage of the device contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook 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.
Event or Problem Description
No new patient or event information to report.

• 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
• MDR Report Key: 10819431
• Report Number: 1820334-2020-02066
• Device Sequence Number: 12295239
• Product Code: DQX
• UDI-Device Identifier: 00827002035621
• UDI-Public: (01)00827002035621(17)250724(10)13287690
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 06/02/2021

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: Health Professional
• Device Expiration Date: 07/24/2025
• Device Model Number: N/A
• Device Catalogue Number: THSF-35-260-AES
• Device Lot Number: 13287690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 05/05/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 01/05/2021; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1