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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One amplatz extra-stiff support heparin coated wire guide was returned for evaluation.Inspection of the device noted that the distal soldered tip was separated at approximately 4mm.The coil looked stretched causing the wire to be elongated at the distal end.The stretched coil measures approximately 1mm in its elongated state.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
An international customer reported that the tip of the amplatz extra-stiff support heparin coated wire guide may have separated.There was no reported patient involvement or injury.

• Brand Name: AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6740023
• Report Number: 1820334-2017-02068
• Device Sequence Number: 821758
• Product Code: DQX
• UDI-Device Identifier: 00827002082809
• UDI-Public: (01)00827002082809(17)210610(10)6985071
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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-SGH-BH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2017
• Initial Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1