MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G01290
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: dawson mueller catheter, 8.5f.Occupation: other non-healthcare professional: buyer.Pma/510k #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an abscess drain placement a bentson straight fixed core wire guide unraveled as the device was being removed.The wire guide had been advanced through the abdomen through another manufacturers catheter.As the wire guide was being removed resistance was felt and it unraveled.The procedure had to be restarted with another wire guide and catheter.No portion of the device remained inside the patient.It did not result in any additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this occurrence.
Additional Manufacturer Narrative
Description of event: as reported, during an abscess drain placement a bentson straight fixed core wire guide unraveled as the device was being removed.The wire guide had been advanced through the abdomen through another manufacturers catheter.As the wire guide was being removed resistance was felt and it unraveled.The procedure had to be restarted with another wire guide and catheter.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, manufacturing instructions, quality control data, and specifications.One wire received used.Inspection found the distal weld was broken resulting in severe coil elongation.The wire was received inserted through a blue flexible stiffener.Stiffener was able to be removed without difficulty.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.Cook has also reviewed the product labeling for this device however there is no information that pertains to the reported failure.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that a cause for this event cannot be established.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information to report.

• Brand Name: BENTSON STRAIGHT 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: 10509740
• Report Number: 1820334-2020-01650
• Device Sequence Number: 11503666
• Product Code: DQX
• UDI-Device Identifier: 00827002012905
• UDI-Public: (01)00827002012905(17)250615(10)13194317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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 Expiration Date: 06/15/2025
• Device Model Number: G01290
• Device Catalogue Number: TSFB-35-180
• Device Lot Number: 13194317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR