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

Catalog Number	TSCF-35-50-3
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info) unknown as not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
The patient was having their annual cecostomy tube changed.A cecostomy tube was placed over guidewire in patient.The guidewire got stuck upon removal and unraveled.There may have been some wire left in the body.The user ended up cutting the cecostomy tube along with the stuck guidewire and thread a new guidewire inside, resulting in having to re-do the procedure with a new cecostomy and guidewire.
Additional Manufacturer Narrative
Investigation/evaluation during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, documentation, specifications, trends, dimensional verification, manufacturing instructions, and a drawing of the returned used and damaged product was conducted.Photos and one used and damaged wire guide were returned for investigation.An examination of the determined the wire guide had two kinks; 10.7 cm and 36.1 cm from the proximal end.It was also noted that the intact wire guide was 41.8 cm.And the core and safety wire were exposed.The exposed core wire was 5.3 cm (total length of 47.1).The exposed safety wire was 9.4 cm.The elongated coil was 93.0 cm.Approximately 3 cm of the core wire guide was missing.This device was inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections during the manufacturing process and again, prior to transport.Although it is plausible to suggest that the wire guide met with resistance beyond its intended design during a procedurally related event; based on the information provided and the investigation of the returned complaint device, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
The patient was having their annual cecostomy tube changed.A cecostomy tube was placed over guidewire in patient.The guidewire got stuck upon removal and unraveled.There may have been some wire left in the body.The user ended up cutting the cecostomy tube along with the stuck guidewire and thread a new guidewire inside, resulting in having to re-do the procedure with a new cecostomy and guidewire.

• Brand Name: SAFE-T-J 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: 5656625
• Report Number: 1820334-2016-00319
• Device Sequence Number: 350737
• Product Code: DXQ
• UDI-Device Identifier: 00827002005242
• UDI-Public: (01)00827002005242(17)210115(10)6475818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TSCF-35-50-3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other