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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported the physician observed the stainless steel mandril exposed outside the tfe on the amplatz extra-stiff support wire guide while he was shaping the wire.This occurred prior to any patient contact.The patient did not experience any adverse effects and did not require any additional procedures as a result of this incident.
Additional Manufacturer Narrative
Clarification of acronym.Product code dqx.Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used amplatz extra-stiff support wire guide was returned for evaluation.The core was exposed 9 millimeters at 5.1 centimeters from the distal end.No coating defects were noted.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the available information and the appearance of the returned device, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported the physician observed the stainless steel mandril exposed outside the polytetrafluoroethylene (ptfe) on the amplatz extra-stiff support wire guide while he was shaping the wire.This occurred prior to any patient contact.The patient did not experience any adverse effects and did not require any additional procedures as a result of this incident.

• 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: 6520945
• Report Number: 1820334-2017-00821
• Device Sequence Number: 19029776
• Product Code: DXQ
• UDI-Device Identifier: 00827002040014
• UDI-Public: (01)00827002040014(17)210801(10)7119395
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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: N/A
• Device Catalogue Number: THSF-35-300-AES
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1