MAUDE Adverse Event Report: COOK INC AMPLATZ WHISKER EXTRA-STIFF SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G07515
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: postal code: (b)(4).Pma/510k #: preamendment.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, during a balloon dilation and using a amplatz whisker extra-stiff support wire guide, an abnormality occurred in the tip of the wire guide.The abnormality was noted to most likely be the protrusion of the core wire but is not certain and was noted during insertion into the patient's body.Access was gained through the femoral artery.Another same type device was used to complete the procedure.No adverse effects have been reported due to the alleged malfunction.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a balloon dilation and using a amplatz whisker extra-stiff support wire guide, an abnormality occurred in the tip of the wire guide.The abnormality was noted to most likely be the protrusion of the core wire but is not certain and was noted during insertion into the patient's body.Access was gained through the femoral artery.Another same type device was used to complete the procedure.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, and quality control data.The complainant returned the complaint wire to cook for investigation.Physical examination of the returned device showed: one used wire guide was received in the wire guide holder.Excessive biomatter was noted throughout the device and holder.The distal weld ball was intact, and the mandril wire was protruding from the wire guide.Wire guide tip was curved, potentially hand made.At this time, cook concluded that the device was manufactured to specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The rpn thsf-35-260-aesw is not supplied with an instruction for use (ifu).A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a component failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook 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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: AMPLATZ WHISKER EXTRA-STIFF SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11007942
• Report Number: 1820334-2020-02293
• Device Sequence Number: 3081455
• Product Code: DQX
• UDI-Device Identifier: 00827002075153
• UDI-Public: (01)00827002075153(17)241016(10)10054152
• 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,Followup
• Report Date (Section B): 06/03/2021

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: 10/16/2024
• Device Model Number: G07515
• Device Catalogue Number: THSF-35-260-AESW
• Device Lot Number: 10054152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 03/01/2021; 05/05/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/22/2021; 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1