MAUDE Adverse Event Report: MEDTRONIC, INC ANGIOGRAPHIC GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	007044
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 guidewire was attempted to be used.No damage was noted to the packaging.No issues were noted when removing the device from the packaging per ifu.The device was prepped per ifu with no issues noted.The wire tip was formed by the physician.The coating was moistened prior to use.It is stated that wires are taken out of the packaging and are sometimes left on the table under a moist towel but not soaked in a bowl of normal saline.It was noted that when the wire was wiped down with normal saline and a typical gauze, small bits of green material and green staining were identified on the gauze sponge.It is indicated that the wiping took place after the device was removed from the patient.It cannot be confirmed if there were any fragments left in the patient.No patient injury reported.
Additional Manufacturer Narrative
Analysis update: towards the distal end, the coating appeared to be flaking as opposed to peeling.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
Product analysis: one 0.038¿ j tip fixed core angiowire was returned, lot# gfcw3018 matching the complaint file.The returned device appeared to have dried saline along the coils.During visual analysis, the outer coils were intact, and the core wire was not exposed.At the very proximal end of the wire, the coating appears to have flaked off the outer coils.The middle of the wire exhibited flaking of the ptfe coating.Towards the distal end, the coating appeared to be peeling.The distal ball tip joint and distal end exhibited flaking of the coating.The wire was passed through fingers with gloves, resulting in no coating coming off or peeling.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: gauze used during the procedure was not returned with the wire.No deformation was noted to the returned 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.Proximal, middle, and distal sections of the wire were wiped with saline-soaked gauze, after which no coating was noted to transfer onto the gauze.No other deformation was noted.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: 8564835
• Report Number: 1220452-2019-00056
• Device Sequence Number: 16953132
• Product Code: DQX
• UDI-Device Identifier: 00643169856738
• UDI-Public: 00643169856738
• 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,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: 09/28/2023
• Device Model Number: 007044
• Device Catalogue Number: 007044
• Device Lot Number: GFCW3018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 08/02/2019; 09/16/2019; 12/20/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/30/2019; 08/27/2019; 10/08/2019; 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1