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

Model Number	G03562
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.Customer name and address= phone: (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 a "bav" procedure via femoral approach, an amplatz extra-stiff support wire guide was found to be elongated upon removing the device from the package.Sharp edges were noted.The device did not make patient contact.The wire guide was not manually shaped.Another device was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Description of event: as reported, prior to a "bav" procedure via femoral approach, an amplatz extra-stiff support wire guide was found to be elongated upon removing the device from the package.Sharp edges were noted.The device did not make patient contact.The wire guide was not manually shaped.Another 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, manufacturing instructions, quality control data, and specifications.One prior to use amplatz extra-stiff support wire guide was received.The safety wire was disconnected from the distal weld.Elongation started at 3cm from distal weld with a length of 10cm.No other issues were identified.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.There are no instructions for use packaged with this device.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.There is no evidence to suggest that manufacturing issues were the cause of this complaint.Based on the investigation results it was most likely that the device was inadvertently damaged during either shipment or storage.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.
Event or Problem Description
No new patient or event information to report.
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
Blank fields on this form indicate the information is unknown or unavailable.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.

• Brand Name: AMPLATZ 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: 10927138
• Report Number: 1820334-2020-02202
• Device Sequence Number: 3081452
• Product Code: DQX
• UDI-Device Identifier: 00827002035621
• UDI-Public: (01)00827002035621(17)251006(10)13441050
• 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: 10/06/2025
• Device Model Number: G03562
• Device Catalogue Number: THSF-35-260-AES
• Device Lot Number: 13441050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 03/09/2021; 05/05/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/19/2021; 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1