MAUDE Adverse Event Report: COOK INC CANTATA 2.9 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Found hair in unopened cantata packaging.The customer reported that, upon inspection of the cantata 2.9 superselective microcatheter, a hair was discovered in the packaging.The device was not opened; accordingly, no patient contact was made, and no adverse events occurred.The customer declined to provide additional information regarding the incident.The product was returned for evaluation, and the investigation is currently pending.
Additional Manufacturer Narrative
Pma/510(k) #: k131772.A review of complaint history, device history record, documentation, specifications, quality control data and visual inspection of the device was conducted during the investigation.The product was returned.Investigation of the product confirmed the presence of foreign matter in the sealed packaging.The manufacturing documents in place at the time of manufacture were reviewed, and it was found that the packaging was visually inspected by quality control and no notable gaps in production or processing controls were identified.The risk specification for this product includes the failure mode for packaging not keeping the device sterile and for not and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The device history record for lot number 7773220 was reviewed.No non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number at the time of investigation.The root cause of this event is manufacturing related - foreign matter as evidenced by the photos sent by the customer and examination of the returned device.The device is out of specification as it is contaminated with foreign matter.The complaint is confirmed based on customer testimony and examination of the returned device.We have notified the appropriate personnel and will continue to monitor for similar events.Per the quality engineering risk assessment no further action is required.

• Brand Name: CANTATA 2.9 SUPERSELECTIVE MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6865503
• Report Number: 1820334-2017-02904
• Device Sequence Number: 636437
• Product Code: KRA
• UDI-Device Identifier: 10827002345826
• UDI-Public: (01)10827002345826(17)191110(10)7773220
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• 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: N/A
• Device Catalogue Number: MCS-2.9-NT-135-15-HP
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 09/14/2017
• 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