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

Model Number	G00691
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: buyer.Pma/510k #: k171764.Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 a left heart catheterization, a bentson straight fixed core wire guide was noted to be frayed and had a kinked, misshaped tip.This was noted after the device was pulled out of a catheter.The procedure was successfully completed with another device of the same type.No unintended section of the device remained inside of the patient.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a left heart catheterization, a bentson straight fixed core wire guide was noted to be frayed and had a kinked, misshaped tip.This was noted after the device was pulled out of a catheter.The procedure was successfully completed with another device of the same type.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 (dhr), drawings, the instructions for use, and quality control data.The complainant returned tsfb-35-145 (bentson straight fixed core wire guide) to cook for investigation.Physical examination of the returned device showed wire protrusion located 8cm from the distal tip.The weld ball was intact.Coil elongation was located 13.1cm from the distal tip and measured 8mm in length.In response to this incident, cook reviewed the dhr.The dhr for lot 13796128 records one related non-conformance; all affected devices were scrapped and not replaced.A database search for complaints on the reported lot found no additional complaints reported from the field.Although relevant non-conformances were reported, the device goes through 100% inspections for the reported non-conformances, all nonconforming product was scrapped, and no additional relevant complaints have been reported from this lot.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings ¿avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A shard edge may scrape or shear material from the wire guide.¿ precautions ¿inspect the wire guide for kinks or damage prior to use.¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ 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 component failure unrelated to manufacturing or design deficiencies contributed to this incident.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.

• Brand Name: BENTSON STRAIGHT FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• MDR Report Key: 11893545
• Report Number: 1820334-2021-01411
• Device Sequence Number: 4268299
• Product Code: DQX
• UDI-Device Identifier: 00827002006911
• UDI-Public: (01)00827002006911(17)260325(10)13796128
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/29/2021

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: 03/25/2026
• Device Model Number: G00691
• Device Catalogue Number: TSFB-35-145
• Device Lot Number: 13796128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1