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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A safe-t-j amplatz extra-stiff support heparin coated wire guide was used in a transcatheter aortic valve replacement for a patient with aortic valvular stenosis.It was reported that after the device was advanced into the patient, the sheath was advanced over the wire guide (access site unknown) and felt abnormal.The physician retrieved the wire guide and observed that the spring coil of the wire guide was damaged/elongated.Another wire guide was used to complete the procedure.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.
Additional Manufacturer Narrative
A review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used safe-t-j amplatz extra-stiff support heparin coated wire guide was returned for investigation.The wire guide is elongated.Distal weld is attached to the coil wire but not the core wire.The wire starts to elongate from 251.5cm from proximal end to 258cm.A bend is noted at 259.5cm from the proximal end.A white dry substance was noted from 247.9cm to 251.5cm from the proximal end.A 7mm curve is noted at the distal end.The device met diameter and length requirements.Review of the device history record of the finished lot shows twelve scrapped and five re-worked products.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.

• Brand Name: SAFE-T-J 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: 6834437
• Report Number: 1820334-2017-02767
• Device Sequence Number: 660041
• Product Code: DQX
• UDI-Device Identifier: 00827002116849
• UDI-Public: (01)00827002116849(17)220503(10)7800678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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: THSCF-35-260-3-AES-SGH-BH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1