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

Model Number	G03562
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.(b)(6).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, during implantation of a biliary stent, the amplatz extra-stiff support wire guide split from the coating.An unknown balloon was advanced over the guide wire and the user reportedly found the wire guide shape abnormal "under dsa".The wire guide was then removed from the patient with the balloon.Approximately ten centimeters of the distal end of the wire guide was observed to be protruding from the coating.The user replaced the device and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects 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
Summary of event: as reported, during implantation of a biliary stent, the amplatz extra-stiff support wire guide split from the coating.An unknown balloon was advanced over the guide wire and the user reportedly found the wire guide shape abnormal "under dsa".The wire guide was then removed from the patient with the balloon.Approximately ten centimeters of the distal end of the wire guide was observed to be protruding from the coating.The user replaced the device and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, and a visual inspection of the complaint device was conducted during the investigation.Visual inspection of the complaint device found that one wire guide was returned in a damaged condition.1.9cm of mandril wire was protruding from the coils at 7cm from distal end.No damage was noted to the distal solder.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 complaint file, device history record, complaint history, and manufacturing documents provide evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Sufficient controls are in place to detect this failure mode prior to release.Based on the information provided and the results of the investigation, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.The risk analysis for this failure mode was reviewed and no action is 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 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: 9451246
• Report Number: 1820334-2019-03083
• Device Sequence Number: 16872231
• Product Code: DQX
• UDI-Device Identifier: 00827002035621
• UDI-Public: (01)00827002035621(17)240212(10)9470954
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 02/12/2024
• Device Model Number: G03562
• Device Catalogue Number: THSF-35-260-AES
• Device Lot Number: 9470954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 61