MAUDE Adverse Event Report: COOK INC SAFE-T-J AMPLATZ WHISKER EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G12232
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.Initial reporter: customer name and address= (b)(6).Pma/510(k) number = pre-amendment.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
As reported, prior to an unknown procedure, a safe-t-j amplatz whisker extra-stiff support heparin coated wire guide was found to be unraveled upon opening the package.Reportedly, the device was unraveled three to four centimeters from the tip.The device did not make patient contact.Another device was used instead to complete the procedure.There has been no report that the patient experienced any adverse effects due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, prior to an unknown procedure, a safe-t-j amplatz whisker extra-stiff support heparin coated wire guide was found to be unraveled upon opening the package.Reportedly, the device was unraveled three to four centimeters from the tip.The device did not make patient contact.Another device was used instead to complete the procedure.There has been no report that the patient experienced any adverse effects due to this event.Investigation evaluation: a review of the complaint history, device history record, manufacturing instructions, and quality control procedures was conducted during the investigation, as well as a visual inspection of the complaint device.Inspection of the complaint device confirmed mandril protrusion beginning 1.7 centimeters from the apex of the curve.The length of protrusion was two millimeters.A document-based investigation evaluation was performed.A review of the device history record revealed no related nonconformances associated with this lot.A complaint history search revealed no other complaints associated with this lot number.There is no evidence to suggest from the complaint file, device history record, complaint history, design verifications, device validations, manufacturing documents, or device failure analysis that the device was manufactured out of specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.No gaps in the manufacturing or quality control processes were found.Investigation has concluded that there is objective evidence to suggest that the device was manufactured to specification.While the reason for the failure could not be determined, a possible reason for the failure may include the shipping and/or handling of the packaging/device.Risk was reviewed for this event and no risk mitigating activity is recommended at this time.The appropriate personnel have been notified and cook will continue to monitor for similar events.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: SAFE-T-J AMPLATZ WHISKER EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9396358
• Report Number: 1820334-2019-02991
• Device Sequence Number: 16635360
• Product Code: DQX
• UDI-Device Identifier: 00827002122321
• UDI-Public: (01)00827002122321(17)240907(10)9948284
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 09/07/2024
• Device Model Number: G12232
• Device Catalogue Number: THSCF-35-260-3-AESW-BH
• Device Lot Number: 9948284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1