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
An angiographic guide wire catheter was attempted to be used during a procedure.No damage was noted to the packaging.The device was removed from the packaging as per ifu with no issues.The device was prepped per the ifu with issues noted.The coating was moistened prior to use.It is reported that during normal wiping with a 4 x 4 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 cannot be confirmed if there were any fragments left in the patient.No patient injury is reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: one 0.035¿ j tip fixed core angiowire was returned, lot# gfdn0555 matching the complaint file.During visual analysis, the outer coils were intact, and the core wire was not exposed.There appeared to be flaking of the ptfe coating at the proximal end of the wire.Coating was noted to be coming off at certain sections along the middle of the wire.The distal tip shows slight flaking of the coating on the outer coils.The wire was passed through fingers with gloves, resulting in no coating coming off.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.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.
Additional Manufacturer Narrative
Correction: the device returned coiled in the opened sterile sleeve.Lot#gfdn0555 matching the complaint file.Gauze used during the procedure was not returned with the wire.There was no deformation noted to the wire.The proximal and distal ends of the wire exhibited normal distribution of the ptfe coating, considering the wire was used.Coating appeared to be patchy along the middle of the wire.Coating did not come off the wire when it was handled.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: 8560094
• Report Number: 1220452-2019-00053
• Device Sequence Number: 19295794
• 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): 01/15/2020

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: GFDN0555
• 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: 04/23/2019; 08/02/2019; 12/20/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 04/29/2019; 08/27/2019; 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1