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

Model Number	G23773
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k122917.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The distributor reported that during inspection of the coda balloon catheter it was observed that there was a hair inside the primary package.This product was not used on a patient.There was no patient involvement.
Additional Manufacturer Narrative
The qc specifications, device history record for the lot number involved was reviewed.There was one non conformance noted for foreign matter in the packaging seal, which was reworked.A complaint search revealed this complaint to be the only reported complaint associated to the complaint lot number 7853508.Retraining was conducted, due to the hair inside the primary package which was observed during inspection at the distribution facility.Manufacturing related/foreign matter has been determined as the root cause.We will notify the appropriate personnel and continue to monitor for similar complaints.No adverse events on patient was noticed due to this occurrence.

• 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: 6969829
• Report Number: 1820334-2017-03495
• Device Sequence Number: 19135376
• Product Code: DQY
• UDI-Device Identifier: 00827002237735
• UDI-Public: (01)00827002237735(17)200424(10)7853508
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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 Model Number: G23773
• Device Catalogue Number: CODA-2-10.0-35-140-46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1