MAUDE Adverse Event Report: COOK INC AMPLATZ STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G28781
Medical Device Problem Codes	Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.(b)(6).Occupation = clinical products advisor.Pma/510(k) number = pre-amendment 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 placement of a drainage catheter, an amplatz stiff support wire guide delaminated and unraveled.Another manufacturer's 5 french catheter was placed through the right abdominal wall in the pelvis.The wire was introduced and felt "crunchy" after a few manipulations.No flaking material was reported.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Upon review of initial dfaf, performed (b)(6) 2020, the wire guide was found to be separated and elongated.The safety wire was also exposed.No delamination was mentioned.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report as reported, during placement of a drainage catheter, an amplatz stiff support wire guide delaminated and unraveled.Another manufacturer's 5 french catheter was placed through the right abdominal wall in the pelvis.The wire was introduced and felt "crunchy" after a few manipulations.No flaking material was reported.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional info: b5 upon review of initial dfaf, performed (b)(6) 2020, the wire guide was found to be separated and elongated.The safety wire was also exposed.No delamination was mentioned.Investigation ¿ evaluation reviews of the complaint history, device history record, documentation, drawing, manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the one used wire was returned.Inspection found the wire was separated approx.1.5cm from the distal weld.The weld ball was intact.The coil elongation was present as well as safety wire exposure.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record showed one nonconforming event which could potentially be related to this failure mode.However, the affected unit was scrapped and not replaced.It should also be noted there were no other reported complaints for this lot number.No gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be determined.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: AMPLATZ STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10201746
• Report Number: 1820334-2020-01208
• Device Sequence Number: 922397
• Product Code: DQX
• UDI-Device Identifier: 00827002287815
• UDI-Public: (01)00827002287815(17)250416(10)13094522
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

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: 04/16/2025
• Device Model Number: G28781
• Device Catalogue Number: THSF-35-180-ASG
• Device Lot Number: 13094522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 05/05/2021
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/10/2020; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENCKOFF CATHETER, 5FR BERN CATHETER