MAUDE Adverse Event Report: COOK INC FLEXOR GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KCFW-7.0-35-30-RB
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that prior to patient contact upon opening the flexor guiding sheath package, the physician noticed that there was unidentified foreign matter adhering on the check-flo valve.The procedure was able to be successfully completed using another device.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed; however, images were provided for review.During visual examination of the image of the complaint device, following was observed: a dark spot [non-floating] inside the primary package.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing quality control documentation, "examine entire package for defects.Reject package if it contains any visible cuts, holes or foreign matter (dirt, hair, paper, fuzz, and et cetera)." based on the information provided and the results of our investigation, the root cause of this event can likely be attributed to foreign matter introduction during the packaging process.However, we are unable to confirm that this occurred during manufacturing as the product was opened and not returned for evaluation.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7083590
• Report Number: 1820334-2017-04351
• Device Sequence Number: 19150658
• Product Code: DYB
• UDI-Device Identifier: 00827002082731
• UDI-Public: (01)00827002082731(17)200811(10)8137980
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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 Catalogue Number: KCFW-7.0-35-30-RB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1