MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

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	10/06/2017
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
During inspection of a flexor high-flex ansel guiding sheath, it was reported that there was a "piece of an unidentified particle inside the primary package".There was no patient involvement in the reported event.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore a physical examination could be performed.The images provided show a dark sport inside the primary package of the device.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this event.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 quality control documentation, "examine entire package for defects.Product must be free of any visible cuts, holes, or foreign matter (dirt, hair, paper, fuzz, etc.)." based on available information and the results of our investigation, the root cause for this event was determined to be foreign matter introduction during the manufacturing process.Appropriate measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6963243
• Report Number: 1820334-2017-03551
• Device Sequence Number: 10904384
• Product Code: DYB
• UDI-Device Identifier: 00827002562226
• UDI-Public: (01)00827002562226(17)200605(10)7965234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: KCFW-7.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1