MAUDE Adverse Event Report: COOK INC AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	AUS-035145-DF
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the customer noticed a hair inside the package containing the amplatz ultra stiff ptfe double flexible wire guide.This was noticed prior to use and the device was not used; did not make contact with a patient.
Additional Manufacturer Narrative
Investigation/evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, and specifications.A visual inspection of the returned device was also conducted during the investigation.One unopened package labeled rpn aus-035145-df, label lot number 8343216 was received.Visual examination of the package confirmed a dark color hair loose inside the sealed package.The device history record was reviewed and noted one related non-conformance during the manufacturing process for (1) item with foreign matter, loose.The item was reworked.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 8343216.Based on the evidence presented by the sample, this event has been attributed to a manufacturing event.Additional measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.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: AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7346208
• Report Number: 1820334-2018-00693
• Device Sequence Number: 16282366
• Product Code: OCY
• UDI-Device Identifier: 00827002535688
• UDI-Public: (01)00827002535688(17)201212(10)8343216
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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 Catalogue Number: AUS-035145-DF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1