MAUDE Adverse Event Report: COOK INC BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: purchasing.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, a beacon tip torcon nb advantage angiographic catheter was pulled out of the packaging and the hub detached from the catheter.This event occurred prior to patient contact.No adverse events have been reported upon occurring.No section of the device was left inside the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d9.H3: 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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 05nov2021.Another catheter was used to complete the procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, a beacon tip torcon nb advantage angiographic catheter was pulled out of the packaging and the hub detached from the catheter.Another catheter was used to complete the procedure.This event occurred prior to patient contact.No adverse events have been reported.Investigation evaluation: a review of the complaint history, device history record, manufacturing instructions, and quality control procedures was conducted during the investigation.A visual inspection of the complaint device and personnel interview was also conducted.The complaint device was returned to cook in a prior-to-use condition.The strain relief and hub were separated from the catheter.Upon separating the strain relief from the hub, glue was confirmed to be present.Further analysis of the device, in collaboration with production, concluded that the amount of glue was sufficient, suggesting that the device was built to specification.A document-based investigation evaluation was performed.Two relevant nonconformances were noted; however, affected product was scrapped and not replaced.There are 100% inspections in place to capture the recorded nonconformance.There have been no additional complaints on the lot.The product ifu instructs to inspect the device and package to ensure there is no damage and instructs the user not to use the product if the catheter or packaging is damaged.The ifu cautions that the product should be stored in the original sealed foil package with required labeling.From the information provided upon review of the customer testimony, dmr, dhr, ifu, and inspection of the returned device, cook has concluded that the device was manufactured to specification.There is no evidence of nonconforming product in-house or in the field.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 results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 has been received since the last report was submitted.

• Brand Name: BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12555040
• Report Number: 1820334-2021-02258
• Device Sequence Number: 4584148
• Product Code: DQO
• UDI-Device Identifier: 00827002111936
• UDI-Public: (01)00827002111936(17)230806(10)14119276
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K173289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2022

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
• Device Expiration Date: 08/06/2023
• Device Model Number: N/A
• Device Catalogue Number: HNBR5.0-38-100-P-NS-TEGT
• Device Lot Number: 14119276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/05/2021; 01/17/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/24/2021; 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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
• Patient Sex: Unknown