MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT HEPARIN COATED FIXED CORE 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	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during a drainage catheter placement as treatment for ascites, using a bentson straight heparin coated fixed core wire guide the new wire was noticed to be broken/unraveled/separated when removing the wire.Additional devices used during the procedure were - cheeba needle and dilator.No information about the patient's anatomy was available.The patient did not require any additional treatment, intervention or medications.The procedure was completed with new products.There was no adverse event or injury to the patient as a result of this event.
Additional Manufacturer Narrative
Corrected information: product code: dqx.Additional information: "the wire guide had broken through a needle.This occurs when removing the wire guide inside the needle.There was a sensation at the end of the needle." investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used bentson straight heparin coated fixed core wire guide was returned for investigation.The wire guide is elongated.Coil begins elongating at 133.5cm from the proximal end.The safety wire core is exposed.Welds at proximal and distal ends are present.The mandril is protruding through the coil.The safety wire is detached from the weld at the distal tip.The outer diameter was within specifications.The coil length of the device measured 194.5cm (this is due to the elongation).The core length measured within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Per the customer, the wire was pulled through the needle which may have contributed to the device failure.Therefore, based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was user error related.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: BENTSON STRAIGHT HEPARIN COATED 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: 6654499
• Report Number: 1820334-2017-01372
• Device Sequence Number: 19120065
• Product Code: DXQ
• UDI-Device Identifier: 00827002006928
• UDI-Public: (01)00827002006928(17)200808(10)6042249
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: TSFB-35-145-BH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 DA