MAUDE Adverse Event Report: COOK INC SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE

Model Number	G03547
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Common name & product code = this device is not sold in the united states.However, this device is like/similar to thscf-35-260-3-aes, which is dqx and pre-amendment.(b)(6).Occupation = unknown pma/510(k) number = this device is not sold in the united states.However, this device is like/similar to thscf-35-260-3-aes, which is dqx and pre-amendment(b)(6).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 use, the tip of a safe-t-j amplatz extra-stiff support heparin coated wire guide was "warped" near the distal tip.The complaint device was not used on any patient.Photos of the device show a partial separation near the distal tip of the wire.
Additional Manufacturer Narrative
Correction b5: this information was provided prior to the initial report but was inadvertently omitted - " warped" means snapped/broken.It was unknown if there was any damage to the packaging.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 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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
Correction: b1, h1: upon completion of the investigation into this event, cook has concluded that the observed damage was a bend in the distal tip of the device incurred during transportation and/or storage of the device.There is a visible crease line along the length of the packaging just below the wire guide.It is likely that the device packaging was folded during transport/storage, with the distal end of the coil getting caught in the fold.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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 EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9903292
• Report Number: 1820334-2020-00718
• Device Sequence Number: 19358234
• Product Code: DQX
• UDI-Device Identifier: 00827002035478
• UDI-Public: (01)00827002035478(17)241111(10)10095075
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2020

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: 11/11/2024
• Device Model Number: G03547
• Device Catalogue Number: THSCF-35-260-3-AES-BH
• Device Lot Number: 10095075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 05/28/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/16/2020; 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1