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
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
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
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: two still images were received showing traces of green pfte coating on a gauze.The pattern in which the green coating is positioned is consistent with wiping the wire with a gauze.Blood is also evident on the gauze.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 covidien curity all purpose sponge.The wipes were used with heparinized saline.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: 8503422
• Report Number: 1220452-2019-00044
• Device Sequence Number: 18881513
• 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): 10/10/2019

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?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019; 04/23/2019; 08/06/2019; 09/16/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/11/2019; 05/14/2019; 09/05/2019; 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1