MAUDE Adverse Event Report: COOK INC CANTATA 2.5 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number	MCS-2.5-NT-150-15-HP
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k101450.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 cantata 2.5 superselective microcatheter was found to have a foreign body within the sealed sterile package.This defect was identified at the distribution center during quality inspection.As reported, there was no patient involvement.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Additional information: d10 device available for evaluation? yes, product received on: 20jun2018.Corrected data: a3-gender:n/a.Investigation - evaluation: a review of the complaint history, device history record, quality control and a visual inspection of the returned device was conducted during the investigation.Clinical assessment: at this time, the most probable cause of this event is manufacturing related.The customer returned one microcatheter set in an unopened condition.No damage was apparent on the packaging.A visual examination confirmed the presence of foreign matter in one of the package seals.The device was found to be out of specification for foreign matter.Additionally, a document based investigation evaluation was performed for this device by reviewing quality control instructions.Quality control inspectors are instructed to examine the entire package for defects and to reject the package if it contains any visible cuts, holes or foreign matter.A review of the device history record revealed no relevant nonconformances from this lot number.It should be noted that there were no other complaints reported for this lot number.There was one complaint noted from a similar device lot, however that was for an unrelated failure mode.Based on the information provided, the examination of the returned product, and the results of our investigation, the definitive root cause was determined as cause traced to manufacturing.(quality control deficiency).Foreign matter was present in the device packaging and it subsequently passed quality control.The applicable department was contacted and informed of this complaint.Retraining was completed.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: CANTATA 2.5 SUPERSELECTIVE MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7552840
• Report Number: 1820334-2018-01570
• Device Sequence Number: 1261616
• Product Code: KRA
• UDI-Device Identifier: 10827002545325
• UDI-Public: (01)10827002545325(17)190117(10)6746213
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 11/15/2018

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: Other
• Device Catalogue Number: MCS-2.5-NT-150-15-HP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1