MAUDE Adverse Event Report: COOK INC SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Uncoiled (1659)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a cardiac catheterization, "the wire pulled apart or became uncoiled upon removal; it did not fully break".The needle was already out during the removal attempt.The wire was removed with the catheter.No intervention was required as nothing remained inside of the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.One safe-t-j exchange fixed core wire guide was returned for evaluation.The safety wire and core were not connected at the distal ends.The coil was elongated at the distal end and bends were noted at 37.0 centimeters (cm), 99.0 cm, 121.0 cm, 143.5cm, 149.5 cm and 244.0 cm from the proximal end.The coil began elongating 238.0 cm from the proximal end.A document based investigation evaluation was also)performed.There is no evidence to suggest the product was not made to specifications.The device history record was reviewed and noted 1 non-conformances for a crack coil and related to the device failure.There were no other reported complaints for this lot number.Based on the information provided and results of the investigation 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.

• Brand Name: SAFE-T-J EXCHANGE FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6508057
• Report Number: 1820334-2017-00818
• Device Sequence Number: 1202480
• Product Code: DXQ
• UDI-Device Identifier: 00827002005174
• UDI-Public: (01)00827002005174(17)220228(10)7650280
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/13/2017

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: TSCF-35-260-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1