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

Model Number G23773

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2017

Event Type  malfunction  

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 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.

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
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6969829
• MDR Text Key: 90756351
• Report Number: 1820334-2017-03495
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002237735
• UDI-Public: (01)00827002237735(17)200424(10)7853508
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G23773
• Device Catalogue Number: CODA-2-10.0-35-140-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Date Device Manufactured: 04/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1