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

Catalog Number CGRXT190HS

Device Problems Detachment of Device or Device Component (2907); Material Distortion (2977)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/26/2017

Event Type  Injury  

Event Description

No damage was noted to the cougar guide wire (gw) packaging.No issues were noted removing the wire from the hoop.The wire was inspected and prepped per ifu.The tip was formed by the physician.The intended lesion was in the proximal lad and exhibited mild tortuosity, moderate calcification and was 100% occluded.The lesion was pre-dilated.The guidewire did pass through a previously deployed stent.No resistance was encountered when advancing the guidewire through the stent delivery system, no force was applied.The guidewire was advanced through the dilated lesion, a stent was deployed and when the balloon was deflated and pulled back, the wire was pulled back and noted to be uncoiled.No resistance was encountered when retracting the stent delivery system (sds) over the wire.The core of the wire was kinked and broken and the wire was uncoiled proximal to the radiopaque part, situated at the applicable part of the lad.A balloon was advanced over the very thin uncoiled wire down to the radiopaque part, it was kept taut and the wire was pulled back in one piece.The wire did not get caught on the deployed stent.No patient injury reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis as received, the distal end of the cougar wire is badly damaged, stretched in a distal direction.The wire is stretched in a distal direction.The core wire is broke from the proximal bond.All dimensions indicate there are no missing components.The wire is stretched, core wire broke from bond.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Sem analysis: observations made on both distal and proximal fracture surfaces of the cougar broken core wire complaint appear to be similar- many small dimples that are mostly uniformly distributed in the direction of applied stress, a typical tensile failure feature with considerable deformation ductility even though there were no outward sign of a cup-and-cone features.There appears to be shear bands or localized higher deformations of shear strain on a small portion of the outer edge on both fracture surfaces.These run perpendicular to the fracture plane that likely preceded failure.Cine image review: on review of the procedural images it appears that the patient has a blocked lad proximally at the site of calcification and a prior stent.There is a patent lima to the distal lad.The wire is acutely bent in the distal lad approximately at the site of disruption.This acute flexion is seen from one of the earliest angio runs and remains acutely bent for the majority of the procedure, up until the wire is repositioned in the first diagonal artery.Numerous balloons are run on the wire.Small balloons inflated in the proximal lesion show that the stent/lesion does not release until a large balloon is inflated in the lesion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COUGAR GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6672617
• MDR Text Key: 78548915
• Report Number: 1220452-2017-00060
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 20643169453320
• UDI-Public: 20643169453320
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K032899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2019
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G16A08951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100