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 Patient Involvement (2645)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.Initial reporter occupation: ir manager.Pma/510(k) #: preamendment.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
It was initially reported an amplatz extra-stiff support wire guide was selected for use in an unknown patient for an unknown procedure.As reported, "wire came out of package crumpled at distal tip." the device did not make patient contact.Upon return of the complaint product on 11jun2019, it was found the mandril was protruding from the outer lumen of the wire.This report was created to document this protrusion.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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.A review of the complaint history, device history record, manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.One wire guide was returned in a damaged condition for investigation.The wire guide was removed from the wire guide holder.The holder was not returned.No biomatter was observed along the wire.A small portion of the inner wire was sticking out of the outer coiling.No other surface damage was observed.Both distal and proximal solders were intact.The outer diameter of the wire guide was measured to be within the correct specifications and tolerances.There is no evidence to suggest the device was not manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record revealed no related nonconformances.A review of the subassembly lot revealed no related nonconformances.A database search revealed no other complaints have been reported for the complaint device lot.As there are no related nonconformances and no other complaints reported from the field, there is no evidence to suggest there is any nonconforming product in house or out in the field.Based on the information provided, inspection of returned product and the results of the investigation, a definitive cause could not be established.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.

• 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: 8711832
• Report Number: 1820334-2019-01477
• Device Sequence Number: 13874224
• Product Code: DXQ
• UDI-Device Identifier: 00827002040038
• UDI-Public: (01)00827002040038(17)240415(10)9636117
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 08/05/2019

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: 04/15/2024
• Device Model Number: N/A
• Device Catalogue Number: THSF-35-80-AES
• Device Lot Number: 9636117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1