MAUDE Adverse Event Report: MEDTRONIC, INC 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	04/05/2019
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 attempted to be used during a procedure.No damage noted to packaging.No issues noted to device when removing from the packaging as per ifu.The device was prepped per ifu with no issues.The wire tip was formed by the physician.It is reported that there was a wire coating issue.As per the nurse who reported the incident to the materials coordinator, during normal wiping with a gauze as per intraprocedural technique, green residue was noted on the pad, suggesting the green coating on the wire was breaking off.It is indicated that the device entered the patient body.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: two still images were received for analysis.In both images white gauze is on display with green flakes/staining of what appears to be ptfe coating, along with some blood.The complaint device is not pictured.Product analysis: device not decontaminated due to nature of complaint.The device returned in the hoop within the sterile packaging lot# gfdn0560, which had been opened.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 also apparent to a number of sections along the middle of the wire, as well as at the distal end.It was also noted that a section of wire in the middle was completely stripped of coating.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 transfer of green coating was seen on the gauze.Some saline was then poured onto the returned gauze and a different section of the wire was wiped.Green coating was seen to transfer onto the gauze once again.Correction 09 july 2019: nothing had changed regarding the protocol on how devices are wiped down.Units are stored in a nearby office location in addition to inside the cath lab itself.The wipes used at the account are either from the pack or are coviden curity all purpose sponge (ref 8047).The wipes were used with heparinized saline.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it is stated that wires are removed from the packaging, left on the table under a moist towel but not soaked in a bowl of normal saline.It is indicated that the wiping was done after removal of the device from the patient body.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis correction: blood was evident on the wire.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): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8503571
• Report Number: 1220452-2019-00046
• Device Sequence Number: 10812667
• Product Code: DQX
• UDI-Device Identifier: 00643169857124
• UDI-Public: 00643169857124
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,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: 12/28/2023
• Device Catalogue Number: 008631
• Device Lot Number: GFDN0560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 08/02/2019; 09/16/2019; 12/19/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/14/2019; 08/28/2019; 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