MAUDE Adverse Event Report: VASCULAR DANVERS MFG ANGIOGRAPHIC GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	008631
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An angiographic wire was used during a procedure.There was no damage noted to the device packaging.There were no issues removing the device from the packaging as per ifu.The device was not inspected.The device was prepped as per ifu.The wire tip was not formed by the physician.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that green coating came off after the wire was withdrawn from the patient.The coating was noted on the 4 x 4 wipe during the procedure from the exchange wire.The wipe was wet with normal saline solution.The patient is alive with no injury.
Additional Manufacturer Narrative
Faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: two still images were received.The first image shows the sterile packaging sticker.The information on the sticker corresponds with what was received from the account.The second image shows a piece of gauze on which blood and green staining, which is thought to be the ptfe coating that reportedly came off the wire.Product analysis: the device returned coiled in the opened sterile packaging.A piece of gauze also returned with what appeared to be ptfe coating embedded on it.No deformation was evident to the wire.The entire length of the wire was viewed under a microscope.It was noted that the proximal end of the wire was almost completely stripped of ptfe coating.Flaking of coating was noted to some sections in the mid-wire.Coating at the distal end of the wire appeared to be somewhat flaked.The wire was wiped with locally-sourced saline-soaked gauze and no ptfe coating was seen to transfer.The wire was then wiped with the returned piece of gauze, after which green coating was seen to transfer onto the gauze.Correction 24 july 2019: heparin flush solution was the only substance used on the device when wiping.Nothing has changed at the account in regards to how devices are wiped down.Devices are stored on a hook behind the door in the cath lab.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: the proximal and distal ends of the wire appeared normal for a used device, when viewed under magnification.Ptfe coating appeared normal in areas, and patchy in other areas along the length of the wire.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANGIOGRAPHIC GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VASCULAR DANVERS MFG; danvers
• MDR Report Key: 8797132
• Report Number: 1220452-2019-00087
• Device Sequence Number: 19592794
• Product Code: DQX
• UDI-Device Identifier: 00643169857124
• UDI-Public: 00643169857124
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/10/2020

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: 02/28/2024
• Device Catalogue Number: 008631
• Device Lot Number: GFDP2861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 09/16/2019; 12/19/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/02/2019; 10/11/2019; 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1