MAUDE Adverse Event Report: COOK INC CANTATA DUO 2.8 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)
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
Foreign material was observed free-floating within the device package.The foreign matter was observed during an evaluation of unused samples returned for a separate complaint investigation.There was no patient contact, accordingly, no adverse patient consequence.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Pma/510(k) #:k101450.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, quality control, specifications, and visual inspection of the device was conducted during the investigation.The device (mcs-2.8-nt2-135-15-hp) lot 7537122 was returned in sealed, undamaged condition.A visual examination noted a black, free floating single strand of foreign matter inside the sterile packaging.No other defects were noted in the packaging.A thorough review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number; 7537122.Additionally, a search of the manufacturer's database revealed this to be the second reported complaint associated to the complaint lot number 7537122.Because the sterile packaging was sealed, it is feasible to suggest the foreign matter was introduced during a manufacturing process.Foreign matter should have been detected during the packaging process and/or during post sterilization.This failure mode has been escalated per internal processes.Per the quality engineering risk assessment no further action is required.We continue to monitor for similar complaints and have notified the appropriate personnel.

• Brand Name: CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6792669
• Report Number: 1820334-2017-02530
• Device Sequence Number: 1038683
• Product Code: KRA
• UDI-Device Identifier: 10827002238050
• UDI-Public: (01)10827002238050(17)190524(10)7537122
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MCS-2.8-NT2-135-15-HP
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1