MAUDE Adverse Event Report: AUROUS CENTIMETER VESSEL SIZING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G11916
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported, during the distributor inspection of an aurous centimeter vessel sizing catheter, an unknown particle was noted inside of the primary packaging of the product.This device did not make patient contact.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: section c description of event: it was reported, during the distributor inspection of an aurous centimeter vessel sizing catheter, an unknown particle was noted inside of the primary packaging of the product.This device did not make patient contact.Investigation ¿ evaluation an inspection of unused product was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.The device was not returned for analysis, however photos were provided.It was evident from the photo that there was an unknown particle inside the packaging.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light 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.A capa was previously opened regarding foreign matter and this capa was closed to the facilities and environmental controls (fec) workstream and the product and process controls (p&pc) workstreams for ongoing efforts to reduce the levels of foreign matter in cinc products.The investigation has found that the most likely cause for this complaint is manufacturing related, more specifically a quality control deficiency.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: AUROUS CENTIMETER VESSEL SIZING CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10118678
• Report Number: 1820334-2020-01062
• Device Sequence Number: 16606236
• Product Code: DQO
• UDI-Device Identifier: 00827002119161
• UDI-Public: (01)00827002119161(17)221014(10)10016064X
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: No Information
• Device Expiration Date: 10/14/2022
• Device Model Number: G11916
• Device Catalogue Number: N5.0-35-100-P-10S-PIG-CSC-20
• Device Lot Number: 10016064X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 11/18/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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