MAUDE Adverse Event Report: COOK INC AMPLATZ ULTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G20320
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: preamendment.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
It was reported, we received product order and during the inspection, it was observed a piece of black hair inside the primary packaging of the product, which is sealed.There was no patient involvement.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the complaint device was not received for an evaluation.Images of the complaint device were provided.A document based investigation was conducted including a review of provided images, complaint history, the device history record, and quality control data.A review of the device history record found there are no non-conformances related to this incident.A review of complaint history records revealed there have been no other complaints associated with the complaint device lot number 8247330.Cook was unable to perform a physical evaluation on the complaint device as the product was not returned.However, the complaint was able to be confirmed based on images of the complaint device returned by the customer.It was identified that a missed verification step in manufacturing qc was the likely cause, but it is also possible that a potential breach and/or compromised packaging integrity could have likely contributed to this incident.The device was not returned in order to inspect the packaging to ensure that the seals remained intact to rule out a potential breach and/or compromised packaging integrity.The definitive conclusion for the reported issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new information received since the last report submission.

• Brand Name: AMPLATZ ULTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8199665
• Report Number: 1820334-2018-03717
• Device Sequence Number: 16533291
• Product Code: DXQ
• UDI-Device Identifier: 00827002203204
• UDI-Public: (01)00827002203204(17)200929(10)8247330
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/22/2019

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 Expiration Date: 09/29/2020
• Device Model Number: G20320
• Device Catalogue Number: THSCF-35-260-3-AUS2
• Device Lot Number: 8247330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1