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	04/09/2019
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
It was reported that during normal wiping of the angiographic wire with a gauze pad, green residue was noted on the pad.It is indicated that the wiping was done after removal from the patient's body.It was suggested that the green coating on the wire was breaking off.It cannot be confirmed if there were any fragments left in the patient.No damage was noted to the packaging, no issues were noted to the device when removing from the packaging per ifu.The device was inspected with no issues and the device was prepped per the ifu.No patient injury reported.
Additional Manufacturer Narrative
Additional information: distribution of ptfe coating at proximal, middle, and distal ends of the wire appeared normal, considering the wire was used.The gauze used to wipe the wire was woven cotton.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.Blood and what appear to be flakes of the green ptfe coating is evident on the gauze.A streak of green on the gauze is visible.Product analysis: one 0.035¿ j tip fixed core angiowire was returned, lot# gfdn2969 matching the complaint file.During visual analysis, the outer coils were intact, and the core wire was not exposed.A kink was noted in the middle of the wire.There appeared to be flaking of the ptfe coating at the proximal end of the wire.Along the middle of the wire no coating came off on either side of the wire.Towards the distal end of the wire, the coils appear slightly stretched.When the wire was passed through fingers with gloves resulting in no coating coming off.Some dried blood was noted along sections of the wire.Proximal, middle, and distal sections of the wire were wiped with saline-soaked gauze, after which no coating was noted to flake or rub off onto the gauze.Additional information; the wipes were used with heparinized saline.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: 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: 8560228
• Report Number: 1220452-2019-00054
• Device Sequence Number: 13849796
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2019

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: 01/28/2024
• Device Catalogue Number: 008631
• Device Lot Number: GFDN2969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 08/01/2019; 07/09/2019; 10/22/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 08/23/2019; 09/05/2019; 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1