MAUDE Adverse Event Report: COOK INC CODA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: k122917.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 a "strange particle" was found inside the primary packaging of a coda balloon catheter.No patient contact was made as the issue was noticed before the product was opened.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the documentation including the complaint history, device history record (dhr), instructions for use (ifu), quality control and specifications, as well as an evaluation of provided photos of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, four photos were provided by the customer for evaluation.In three of the photos, a small, black speck of foreign matter is circled.The observed foreign matter appears loose and not within any of the packaging seals.There is evidence that this device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.Based on the review of current documentation, cook has concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.Process verification has demonstrated that the affected product is safe and effective for its intended use.The device history record (dhr) for the given complaint lot (9586797) was reviewed and found no related non-conformances.Two similar device lots (9586802 and 9591798) were recorded to have left packaging/quality control on the same date as the complaint device lot.Both lots were reviewed, revealing no non-conformances for either.A search of current reporting software found no other reported complaints from the complaint device lot or the other similar inspected lot.Because there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in field.Cook also reviewed product labeling.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 or 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." the complaint was able to be confirmed based on customer testimony and the provided photos.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause can be traced to manufacturing and more specifically to a quality control deficiency.It is likely the device packaging passed through packaging quality control with the foreign matter present.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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 regarding the event has been received since the previous medwatch report was sent.

• Brand Name: CODA BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8983198
• Report Number: 1820334-2019-02266
• Device Sequence Number: 19665689
• Product Code: DQY
• UDI-Device Identifier: 00827002237735
• UDI-Public: (01)00827002237735(17)220313(10)9586797
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/19/2019

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: 03/13/2022
• Device Model Number: N/A
• Device Catalogue Number: CODA-2-10.0-35-140-46
• Device Lot Number: 9586797
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1