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

Model Number	008632
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #703402537: as received, two unraveled angiowires were received severely entangled together.The non-medtronic pigtail catheter used during the procedure was not returned.The wires were untangled and inspected.The coils along the wire of the returned device were stretched.The distal weld was intact with the core and safety wire attached.The coil appeared to have separated from the weld, with a small piece of coil still attached to the weld.No damage noted to the proximal weld.Vendor analysis the distal weld, safety and core wire are still attached to one another.It appears that the spring has separated from the weld section, a small piece of the spring is still attached to the distal weld.The proximal weld appears to still be attached with no abnormalities.The spring is stretched and unraveled effect in appearance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An angiographic wire (pli 10) was used during an aortic stenosis case, during which a straight exchange was employed through a non medtronic pigtail catheter.The device was inspected prior to use with no issues noted.The wire tip was not formed by the physician as it was a 0.038 straight wire.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the wire unraveled in the patient.All of the device was removed from the patient.The patient is alive with no injury.A second wire (pli 30) from the same lot was opened after the case.The wire detached at the distal end during inspection, while being pulled on.The second wire was not used in the case and was not in clinical use.Two additional unopened wires lot#: gfcv3917 were received.Pli 20 added.

• 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: 9719231
• Report Number: 1220452-2020-00022
• Device Sequence Number: 361855
• Product Code: DQX
• UDI-Device Identifier: 00643169857131
• UDI-Public: 00643169857131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: 02/28/2024
• Device Model Number: 008632
• Device Catalogue Number: 008632
• Device Lot Number: GFDQ0484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1